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Document 52022XC1130(04)

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC, Article 38 of Directive 2001/82/EC or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)

PUB/2022/1459

OJ C 457, 30.11.2022, p. 9–17 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

30.11.2022   

EN

Official Journal of the European Union

C 457/9


Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2022 to 31 October 2022

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1), Article 38 of Directive 2001/82/EC (2) or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council (3))

(2022/C 457/02)

—   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

28.10.2022

Nomegestrol and Chlormadinone

nomegestrol or chlormadinone

See Annex

See Annex

31.10.2022


(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

(3)  OJ L 4, 7.1.2019, p. 43.


ANNEX

List of nationally authorised medicinal products

Nationally authorised medicinal products containing nomegestrol

Member State in EEA

Marketing Authorisation Holder

Product Name

INN/Active Substance + Strength

Pharmaceutical Form

Route of Administration

Belgium

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Belgium

Stragen Nordic A/S

Nomegestrol Stragen

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Belgium

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Belgium

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

France

Arrow Generiques

Nomegestrol Arrow

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Biogaran

Nomegestrol Biogaran

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Eg Labo Laboratoires Eurogenerics

Nomegestrol Eg

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Mylan S.A.S

Nomegestrol Mylan

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Sandoz

Nomegestrol Sandoz

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 3,75  mg Tablet

Tablet

Oral Use

France

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

France

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

Italy

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Italy

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

Luxembourg

Ceres Pharma Nv

Nogest

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Luxembourg

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Luxembourg

Theramex Ireland Limited

Naemis

Estradiol Hemihydrate 1,55  mg Tablet | Nomegestrol Acetate 3,75  mg Tablet, Estradiol Hemihydrate 1,55  mg Tablet

Tablet

Oral Use

Poland

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Portugal

Theramex Ireland Limited

Lutenyl

Nomegestrol Acetate 5 mg Tablet

Tablet

Oral Use

Nationally authorised medicinal products containing chlormadinone

Member State in EEA

Marketing Authorisation Holder

Product Name

INN/Active Substance + Strength

Pharmaceutical Form

Route of Administration

Austria

Dermapharm Gmbh

Madinette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Gedeon Richter Plc.

Balanca

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Gynial Gmbh

Bilinda Gynial

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Austria

Kwizda Pharma Gmbh

Delia

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Belgium

Ceres Pharma Nv

Helen

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Belgium

Gedeon Richter Plc.

Bellina

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Belgium

S.A. Meda Pharma N.V.

Orchidea

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Bulgaria

Gedeon Richter Plc.

Белара 21+7

Chlormadinone Acetate 2 mg, Ethinylestradiol 0,03  mg | Lactose Monohydrate 94,44  mg

Film-Coated Tablet

Oral Use

Croatia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Croatia

Mibe Pharmaceuticals D.O.O.

Estal

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Aristo Pharma Gmbh (Art 57)

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Exeltis Czech S.R.O.

Lydely

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Czech Republic

Heaton K.S.

Flaya

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

Coated Tablet

Oral Use

Czech Republic

Stada Arzneimittel Ag

Bonissa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Estonia

Uab Exeltis Baltics

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet

Film-Coated Tablet

Oral

France

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

France

Gedeon Richter Plc.

Belaracontinu

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

France

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Mylan S.A.S

Chlormadinone Mylan

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

France

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Sandoz

Chlormadinone Sandoz

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

France

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Sanofi-Aventis France

Luteran

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

France

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 10 mg Tablet

Tablet

Oral Use

France

Teva Santé

Chlormadinone Teva

Chlormadinone Acetate 5 mg Tablet

Tablet

Oral Use

Germany

Acis Arzneimittel Gmbh

Madinance

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Aliud Pharma Gmbh

Bonita

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Aristo Pharma Gmbh (Art 57)

Lilia

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Besins Healthcare Germany Gmbh

Minette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Balanca

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Belara 21+7

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Chariva

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Chariva 21+7

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat 21+7 Richter

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 94,44  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Ethinylestradiol/Chlormadinonacetat Richter

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Neo-Eunomin

Chlormadinone Acetate 1mg Tablet, Ethinylestradiol 0,05  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Gedeon Richter Plc.

Neo-Eunomin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,05  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Hexal Ag

Mona

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Hormosan Pharma Gmbh

Solera

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Jenapharm Gmbh & Co Kg

Chlormadinon Jenapharm

Chlormadinone Acetate 2 mg Tablet

Tablet

Oral Use

Germany

Jenapharm Gmbh & Co Kg

Enriqa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Meda Pharma Gmbh & Co. Kg

Bellissima

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Meda Pharma Gmbh & Co. Kg

Bellissima 21+7

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Mibe Gmbh Arzneimittel

Madinette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Mylan Germany Gmbh

Lisette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Puren Pharma Gmbh & Co. Kg

Angiletta

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Stadapharm Gmbh

Pink Luna

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Germany

Zentiva Pharma Gmbh

Chloee

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Greece

Elpen Pharmaceutical Co. Inc.

Labous

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Hungary

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Gedeon Richter Plc.

Lybella

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Mylan S.P.A.

Mytulip

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Italy

Sandoz S.P.A.

Eve

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Latvia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Latvia

Uab Exeltis Baltics

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol Ph. Eur. 0,03  mg Tablet

Film-Coated Tablet

Oral

Lithuania

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 30μg Tablet

Film-Coated Tablet

Oral Use

Luxembourg

Ceres Pharma Nv

Helen

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Luxembourg

Gedeon Richter Plc.

Bellina

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Luxembourg

Meda Pharma Gmbh & Co. Kg

Bellissima

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Actavis Group Ptc Ehf.

Angiletta

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Exeltis Poland Sp. Z O.O.

Clormetin

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Gedeon Richter Polska Sp. Z. O.O.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Sun-Farm Sp. Z.O.O.

Madinette

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Poland

Symphar Sp. Z O.O.

Symbella

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Gedeon Richter Plc.

Chariva

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Gedeon Richter Plc.

Libeli

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Itf Farmahealth, Produtos Farmacêuticos, Lda

Clarissa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Portugal

Laboratorios León Farma, S.A.

Bonae

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Romania

Gedeon Richter România S.A.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Romania

Gedeon Richter România S.A.

Belara Continu

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,32  mg Tablet

Film-Coated Tablet

Oral Use

Slovakia

Exeltis Slovakia

Lydely

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Slovakia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Slovakia

Stada Arzneimittel Ag

Belissa

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Slovenia

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Aristo Pharma Iberia, S.L.

Clormadinona/Etinilestradiol Aristo

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Brill Pharma, S.L.

Elynor

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Balianca

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Balianca Diario

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Belara

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Gedeon Richter Plc.

Belara Diario

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet | Lactose Monohydrate 97,3  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Laboratorio Stada, S.L.

Clormadinona/Etinilestradiol Stadafarma

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use

Spain

Laboratorio Stada, S.L.

Etinilestradiol/Clormadinona Stada

Chlormadinone Acetate 2 mg Tablet, Ethinylestradiol 0,03  mg Tablet

Film-Coated Tablet

Oral Use


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