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)
Date: 2022-11-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2022457EN.01000901.xml










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