Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2022 to 31 July 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: 2022-08-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product








C_2022331EN.01001301.xml










31.8.2022   


EN


Official Journal of the European Union


C 331/13






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2022 to 31 July 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 (3) of the European Parliament and of the Council)
(2022/C 331/02)
—   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




18.7.2022


Daruph and Anafezyn and associated names


dasatinib (anhydrous)


See Annex


See Annex


19.7.2022






(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 medicinal products and presentations










Member State EU/EEA


Applicant
company name, address


(Invented) Name


Strength


Pharmaceutical form


Route of administration




France







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 16 mg, comprimé pelliculé (1)



16 mg


film-coated tablet


oral use




France







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 40 mg, comprimé pelliculé1



40 mg


film-coated tablet


oral use




France







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 55 mg, comprimé pelliculé1



55 mg


film-coated tablet


oral use




France







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 63 mg, comprimé pelliculé1



63 mg


film-coated tablet


oral use




France







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 79 mg, comprimé pelliculé1



79 mg


film-coated tablet


oral use




France







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 111 mg, comprimé pelliculé1



111 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 16 mg Filmtabletten


16 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 16 mg Filmtabletten


16 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 40 mg Filmtabletten


40 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 40 mg Filmtabletten


40 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 55 mg Filmtabletten


55 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 55 mg Filmtabletten


55 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 63 mg Filmtabletten


63 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 63 mg Filmtabletten


63 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 79 mg Filmtabletten


79 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 79 mg Filmtabletten


79 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 111 mg Filmtabletten


111 mg


film-coated tablet


oral use




Germany







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 111 mg Filmtabletten


111 mg


film-coated tablet


oral use




Hungary







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 16 mg filmtabletta


16 mg


film-coated tablet


oral use




Hungary







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 40 mg filmtabletta


40 mg


film-coated tablet


oral use




Hungary







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 55 mg filmtabletta


55 mg


film-coated tablet


oral use




Hungary







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 63 mg filmtabletta


63 mg


film-coated tablet


oral use




Hungary







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 79 mg filmtabletta


79 mg


film-coated tablet


oral use




Hungary







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 111 mg filmtabletta


111 mg


film-coated tablet


oral use




Ireland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 16 mg film-coated tablets


16 mg


film-coated tablet


oral use




Ireland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 40 mg film-coated tablets


40 mg


film-coated tablet


oral use




Ireland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 55 mg film-coated tablets


55 mg


film-coated tablet


oral use




Ireland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 63 mg film-coated tablets


63 mg


film-coated tablet


oral use




Ireland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 79 mg film-coated tablets


79 mg


film-coated tablet


oral use




Ireland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn 111 mg film-coated tablets


111 mg


film-coated tablet


oral use




Italy







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


16 mg


film-coated tablet


oral use




Italy







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


40 mg


film-coated tablet


oral use




Italy







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


55 mg


film-coated tablet


oral use




Italy







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


63 mg


film-coated tablet


oral use




Italy







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


79 mg


film-coated tablet


oral use




Italy







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


111 mg


film-coated tablet


oral use




Poland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


16 mg


film-coated tablet


oral use




Poland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


40 mg


film-coated tablet


oral use




Poland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


55 mg


film-coated tablet


oral use




Poland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


63 mg


film-coated tablet


oral use




Poland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


79 mg


film-coated tablet


oral use




Poland







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


111 mg


film-coated tablet


oral use




Portugal







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


16 mg


film-coated tablet


oral use




Portugal







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


40 mg


film-coated tablet


oral use




Portugal







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


55 mg


film-coated tablet


oral use




Portugal







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


63 mg


film-coated tablet


oral use




Portugal







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


79 mg


film-coated tablet


oral use




Portugal







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


111 mg


film-coated tablet


oral use




Romania







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 16 mg comprimate filmate


16 mg


film-coated tablet


oral use




Romania







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 40 mg comprimate filmate


40 mg


film-coated tablet


oral use




Romania







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 55 mg comprimate filmate


55 mg


film-coated tablet


oral use




Romania







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 63 mg comprimate filmate


63 mg


film-coated tablet


oral use




Romania







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 79 mg comprimate filmate


79 mg


film-coated tablet


oral use




Romania







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 111 mg comprimate filmate


111 mg


film-coated tablet


oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 16 mg


16 mg


film-coated tablet


oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 40 mg


40 mg


film-coated tablet


oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 55 mg


55 mg


film-coated tablet


oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 63 mg


63 mg


film-coated tablet


oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 79 mg


79 mg


film-coated tablet


oral use




Slovak Republic







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph 111 mg


111 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


16 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


16 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


40 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


40 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


55 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


55 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


63 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


63 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


79 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


79 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Anafezyn


111 mg


film-coated tablet


oral use




Sweden







Zentiva, k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Daruph


111 mg


film-coated tablet


oral use






(1)  Invented name not accepted by national competent authority, pending new proposal by the applicant.