52022XC1130(04)

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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)

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30.11.2022

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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