Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2026 to 28 February 2026 (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: 2026-03-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_202601842EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/1842


31.3.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2026 to 28 February 2026
         


(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)
)


(C/2026/1842)

—   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




12.2.2026


Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens and associated names


Phenoxymethylpenicillin


See Annex I


See Annex I


13.2.2026




18.2.2006


Melatomed and associated names


melatonin


See Annex II


See Annex II


19.2.2026






(1)  
            OJ L 311, 28.11.2001, p. 67, ELI: https://data.europa.eu/eli/dir/2001/83/oj.

(2)  
            OJ L 311, 28.11.2001, p. 1, ELI: https://data.europa.eu/eli/dir/2001/82/oj.

(3)  
            OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.




ANNEX I
List of the names, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, marketing authorisation holder in the Member States












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Belgium







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Bulgaria







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Czechia







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen 293 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Denmark







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxylin, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




France







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Germany







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Greece







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Hungary







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen 325 mg/g powder for use in drinking water for chickens A.U.V.


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Ireland







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen Water Soluble Powder, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Italy







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Lithuania







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Netherlands







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands.






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Poland







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Portugal







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Romania







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Slovakia







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen WSP, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




Spain







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Avipen, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use




United Kingdom (Northern Ireland)







Dopharma Research B.V.




Zalmweg 24 4941 VX




Raamsdonksveer The Netherlands






Phenoxypen Water Soluble Powder, 325 mg/g powder for use in drinking water for chickens


Phenoxymethylpenicillin


325 mg/g


Powder for use in drinking water


Chicken


In drinking water use









ANNEX II
List of medicinal products and presentations











Member State EU/EEA




Applicant




Product name




Strength




Pharmaceutical form




Route of administration





Austria







Fairmed Healthcare GmbH, Dorotheenstrasse 48, 22301 Hamburg




Germany






Melozostrin 2 mg Retardtabletten


2 mg


Prolonged-release tablet


Oral use




Denmark







Fairmed Healthcare GmbH, Dorotheenstrasse 48, 22301 Hamburg




Germany






Melozostrin


2 mg


Prolonged-release tablet


Oral use




Germany







Fairmed Healthcare GmbH, Dorotheenstrasse 48, 22301 Hamburg




Germany






Melatomed 2 mg Retardtabletten


2 mg


Prolonged-release tablet


Oral use




Sweden







Fairmed Healthcare GmbH, Dorotheenstrasse 48, 22301 Hamburg




Germany






Melozostrin


2 mg


Prolonged-release tablet


Oral use







ELI: http://data.europa.eu/eli/C/2026/1842/oj
ISSN 1977-091X (electronic edition)