# C_2022457EN.01000901.xml

| 30.11.2022 | EN | Official Journal of the European Union | C 457/9 |
| --- | --- | --- | --- |

30.11.2022

EN

Official Journal of the European Union

C 457/9

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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 |

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

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(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.

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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 |

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 |

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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