# C_2022331EN.01001301.xml

| 31.8.2022 | EN | Official Journal of the European Union | C 331/13 |
| --- | --- | --- | --- |

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 |

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.

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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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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.

---