Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 2024 (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: 2024-03-27
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, veterinary medicinal product








C_202402198EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/2198


27.3.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2024 to 29 February 2024
         
(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/2024/2198)

—   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




23.2.2024


Procactive 300 mg/ml suspension for injection for cattle, sheep and pigs and associated names


procaine benzylpenicillin


See Annex


See Annex


26.2.2024






(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 the names, pharmaceutical form, strength of the veterinary medicinal products, 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




Belgium







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Peniyet vet 300 mg/ml suspension injectable pour bovins, ovins et porcins


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Bulgaria







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml инжекционна суспензия за говеда, овце и прасета


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Denmark







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Syvacillin vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Estonia







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml süstesuspensioon veistele, lammastele ja sigadele


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Finland







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Syvacillin vet 300 mg/ml injektioneste, suspensio naudoille, lampaille ja sioille


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




France







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive suspension injectable pour bovins, ovins et porcins


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Germany







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml Injektionssuspension für Rinder, Schafe und Schweine


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Greece







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Syvacillin vet 300 mg/ml ενέσιμο εναιώρημα για βοοειδή, πρόβατα και χοίρους


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Hungary







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml szuszpenziós injekció szarvasmarhák, juhok és sertések számára A.U.V.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Ireland







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml suspension for injection for cattle, sheep and pigs


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Italy







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml sospensione iniettabile per bovini, ovini e suini


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Norway







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Peniyet vet 300 mg/ml injeksjonsvæske, suspensjon til storfe, sau og gris


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Portugal







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml suspensão injetável para bovinos, ovinos e suínos


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Spain







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml Suspensión inyectable para bovino, ovino y porcino


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




Sweden







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Peniyet vet 300 mg/ml injektionsvätska, suspension för nötkreatur, får och grisar


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




The Netherlands







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Peniyet vet 300 mg/ml suspensie voor injectie bij runderen, schapen en varkens


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use




United Kingdom (Northern Ireland)







Laboratorios Syva S.A.U.




Avenida Párroco Pablo Díez,




49-57 (24010) León




Spain






Procactive 300 mg/ml suspension for injection for cattle, sheep and pigs


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pigs


Intramuscular use







ELI: http://data.europa.eu/eli/C/2024/2198/oj
ISSN 1977-091X (electronic edition)