Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2023 to 31 December 2023 (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: 2024-01-31
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, veterinary medicinal product








C_202400911EN.000101.fmx.xml












Official Journal of the European Union


EN
Series C













C/2024/911


31.1.2024






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2023 to 31 December 2023
         
(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)
(C/2024/911)

—   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




11.12.2023


Veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection


Procaine benzylpenicillin


See Annex


See Annex


12.12.2023






(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 veterinary medicinal products












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Vana GmbH




Wolfgang Schmälzl Gasse 6




1020 Vienna




Austria






Vanapen 300 mg/ml Injektionssuspension für tiere


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular use




Austria







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven 300 mg/ml Injektionssuspension für pferde, rinder, schafe, ziegen, hunde, katzen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular, subcutaneous use




Austria







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procain Penicillin G aniMedica 300 mg/ml Injektionssuspension für tiere


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Austria







Ogris Pharma Vertriebs GmbH




Hinderhoferstraße 3




4600 Wels




Austria






Livipen 300 mg/ml Injektionssuspension für rinder, schweine und pferde


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Belgium







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Peniyet vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Belgium







Kela nv




Sint Lenaartseweg 48




2320 Hoogstraten




Belgium






Peni-Kel


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Belgium







V.M.D. nv




Hoge Mauw 900




2370 Arendonk




Belgïe






Deposil


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Belgium







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Belgium







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Bulgaria







Provet S.A.




Posidonos avenue 77




174 55 Alimos, Attiki,




Greece






Pangolamin injectable


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Sheep, pig, dog, cat


Intramuscular use




Bulgaria







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven 300 mg/ml suspension for injection for horses, cattle, sheep, goats, dogs and cats


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular, subcutaneous use




Bulgaria







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen 300 mg/ml, suspension for injection for cattle, pigs and horses


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Bulgaria







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Bulgaria







Alfasan International B.V.




Kuipersweg 9




3449 JA Woerden




The Netherlands






Procpen 30 injectable suspension


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, calve, swine, dog, cat


Intramuscular use




Croatia







Alfasan International B.V.




Kuipersweg 9




3449 JA Woerden




The Netherlands






Procpen 30, 300 mg/ml, suspenzija za injekciju, za goveda, konje, svinje, ovce, koze, pse i mačke


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular use




Cyprus







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen, 300 mg/ml, Ενέσιμο εναιώρημα για βοοειδή, χοίρους και άλογα


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig (adult)


Intramuscular use




Czech Republic







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin 300 mg/ml injekční suspense


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Czech Republic







Kela nv




Sint Lenaartseweg 48




2320 Hoogstraten




Belgium






Peni-Kel 300 mg/ml injekční suspenze


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig, dog


Intramuscular, subcutaneous use




Czech Republic







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen 300 mg/ml, injekční suspenze pro skot, prasata a koně


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig (adult)


Intramuscular use




Czech Republic







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA 300 mg/ml injekční suspenze


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Denmark







ScanVet Animal Health A/S, Kongevejen 66,




3480 Fredensborg,




Denmark






Noropen Prolongatum Vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Pig


Intramuscular use




Denmark







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Denmark







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Ethacilin Vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular use




Denmark







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52, 2100 København Ø




Denmark






Penovet Vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular, subcutaneous use




Denmark







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Denmark







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






SOlong Vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Pig


Intramuscular use




Denmark







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Syvacillin Vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Denmark







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil Vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Estonia







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Estonia







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Procactive


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Estonia







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Estonia







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Estonia







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Finland







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Finland







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52, 2100 København Ø




Denmark






Penovet vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Finland







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen Vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Finland







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Syvacillin Vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Finland







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Ethacilin vet


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




France







Intervet




Rue Olivier de Serres




Angers Technopole




Beaucouze Cedex 49071




France






Depocilline


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular use




France







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Procactive suspension injectable pour bovins et porcins


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




France







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen suspension injectable pour bovins, ovins et porcins


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




France







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil suspension injectable pour bovins, ovins et porcins


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Germany







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procain-Penicillin-G ad us.vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse


Intramuscular, intramammary use




Germany







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13




31303 Burgdorf




Germany






Procillin 30 %


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig, dog


Intramuscular use




Germany







Ceva Tiergesundheit GmbH




Kanzlerstr. 4




40472 Düsseldorf




Germany






Vetriproc 30 %


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Germany







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Procpen WDT 300 mg/ml


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular, subcutaneous use




Germany







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Germany







Dechra Veterinary Products Deutschland GmbH




Hauptstr. 6-8,




88326 Aulendorf




Germany






Procain-Penicillin Susp.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular use




Germany







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Procactive 300 mg/ml Injektionssuspension für rinder und schweine


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Germany







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular, subcutaneous use




Germany







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen 300mg/ml Injektionssuspension für rinder, schafe und schweine


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Germany







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil 300 mg/ml Injektionssuspension für rinder, schafe und schweine


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Greece







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Greece







Intervet Hellas A.E.,




Ag. Dimitriou 63,




174 55 Alimos, Athens




Greece






Depocillin


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular use




Greece







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Greece







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Syvacillin


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Hungary







Kela nv




Sint Lenaartseweg 48




2320 Hoogstraten




Belgium






Neopen szuszpenziós injekció A.U.V.


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, pig, dog, cat


Intramuscular, subcutaneous use




Hungary







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Hungary







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen 300 mg/ml szuszpenziós injekció szarvasmarhák, sertések és lovak számára A.U.V.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Hungary







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven 300 mg/ml szuszpenziós injekció lovak, szarvasmarhák, juhok, kecskék, kutyák és macskák számára A.U.V.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular, subcutaneous use




Hungary







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA 300 mg/ml szuszpenziós injekció szarvasmarhák és sertések számára A.U.V.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Iceland







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52, 2100 København Ø




Denmark






Penovet vet.


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular, subcutaneous use




Ireland







Mevet, S.A.U.




Polígono Industrial El Segre, parcela 409-410




25191 Lérida




Spain






Probencil 300 mg/ml suspension for injection for cattle and pigs


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Ireland







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Ireland







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Ireland







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Ireland







Intervet Ireland Ltd.




Magna Drive Magna Business Park Citywest Road




Dublin 24




Ireland






Depocillin 300 mg/ml suspension for injection


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Ireland







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin 300 mg/ml suspension for injection


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig


Intramuscular use




Ireland







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA 300 mg/ml


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Ireland







Chem-Pharm




Ballyvaughan Co. Clare




Ireland






Pharmacillin 300 mg/ml suspension for injection


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig


Intramuscular use




Ireland







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Ireland







Interchem Ireland Ltd




29 Cookstown Industrial Estate




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Ireland







Univet Limited




Tullyvin Cootehill Co. Cavan.




Ireland






Unicillin 300 mg/ml suspension for injection


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Ireland







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen 300 mg/ml suspension for injection for cattle, pigs and horses


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Italy







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Depocillina 300 mg/ml sospensione acquosa iniettabile per bovini, ovini, suini, equini, cani e gatti


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Italy







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Prontocill 300 000  U.I./ml sospensione iniettabile per bovini, ovini, caprini, suini, equini, cani e gatti


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular, subcutaneous use




Italy







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen 300 mg/ml sospensione iniettabile per bovini, suini e cavalli


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Italy







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Procactive 300 mg/ml sospensione iniettabile per bovini e suini


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Italy







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Italy







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Italy







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen, 300 mg/ml, sospensione iniettabile per bovini, suini e cavalli


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Italy







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven 300 mg/ml


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular use




Latvia







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Latvia







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Latvia







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Latvia







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Lithuania







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin 300 mg/ml, injekcinė suspensija


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Lithuania







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen 300 mg/ml, injekcinė suspensija galvijams, kiaulėms ir arkliams


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Lithuania







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen 300 mg/ml, injekcinė suspensija galvijams, avims ir kiaulėms


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Lithuania







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA 300 mg/ml, injekcinė suspensija


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Luxembourg







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Peniyet vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Luxembourg







Kela nv




Sint Lenaartseweg 48




2320 Hoogstraten




Belgium






Peni-Kel


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




Luxembourg







V.M.D. nv




Hoge Mauw 900




2370 Arendonk




Belgïe






Deposil


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Luxembourg







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Luxembourg







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Malta







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen 300 mg/ml, suspension for injection for cattle, pigs and horses


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig (adult)


Intramuscular use




Norway







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52,




2100 København Ø




Denmark






Penovet vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular, subcutaneous, intraperitoneal, intrasynovial, intrauterine use




Norway







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Peniyet vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Norway







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Norway







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Poland







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Poland







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Poland







ScanVet Polan Sp. z o.o.




Skiereszewo, ul. Kiszkowska 9




62-200 Gniezno




Poland






Longapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use




Poland







ScanVet Polan Sp. z o.o.




Skiereszewo, ul. Kiszkowska 9




62-200 Gniezno




Poland






Penillin 30 %


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular use




Poland







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Penject


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Pig


Intramuscular use




Poland







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Poland







Mevet, S.A.U.




Polígono Industrial El Segre, parcela 409-410




25191 Lérida




Spain






Probencil


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Poland







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Poland







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat


Intramuscular, subcutaneous use




Portugal







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen, 300 mg/ml, suspension for injection for cattle, pigs and horses


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Portugal







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Portugal







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Portugal


MSD Animal Health, Lda.


Depocilina 300 mg/ml suspensão injetável para bovinos, ovinos, suínos, equinos, cães e gatos


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Portugal







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Romania







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Penject 30


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, horse, pig, dog, cat


Intramuscular use




Romania







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Romania







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




The Netherlands






Depocillin


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Romania







WdT — Wirtschaftsgenossenschaft Deutscher Tierärzte eG




Siemensstr. 14




30827 Garbsen




Germany






Taneven


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, dog, cat


Intramuscular, subcutaneous use




Slovak Republic







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin 300 mg/ml injekčná suspenzia


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Slovak Republic







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen, 300 mg/ml, suspenzia na injekciu pre hovädzí dobytok, ošípané a kone


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig (adult)


Intramuscular use




Slovenia







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Livipen 300 mg/ml, suspenzija za injiciranje za govedo, prašiče in konje


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Slovenia







Alfasan International B.V.




Kuipersweg 9




3449 JA Woerden




The Netherlands






Procpen 297,7  mg/ml suspenzija za injiciranje za govedo, prašiče, pse in mačke


Procaine benzylpenicillin


297,7  mg/ml


Suspension for injection


Cattle, pig, dog, cat


Intramuscular use




Spain







Mevet, S.A.U.




Polígono Industrial El Segre, parcela 409-410




25191 Lérida




Spain






Probencil 300 mg/ml suspension inyectable para bovino y porcino


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Spain







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Procactive 300 mg/ml suspension inyectable para bovino y porcino


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Spain







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen 300 mg/ml suspension inyectable para bovino, porcino y caballos


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




Spain







Merck Sharp & Dohme Animal Health, S.L.




Polígono Industrial El Montalvo I




C/ Zeppelin, no 6, parcela 38




37008 Carbajosa de la Sagrada




Salamanca




Spain






Depocillin


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, non-food-producing horse, sheep, pig


Intramuscular use




Spain







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen 300 mg/ml suspension inyectable para bovino, ovino y porcino


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Spain







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil 300 mg/ml suspension inyectable para bovino, ovino y porcino


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Sweden







Boehringer Ingelheim Animal Health Nordics A/S




Strødamvej 52, 2100 København Ø




Denmark






Penovet vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, goat, pig, dog, cat


Intramuscular use




Sweden







Intervet International BV, P.O. Box 30 5830 AA Boxmeer,




The Netherlands






Ethacilin vet.


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




Sweden







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






Peniyet vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




Sweden







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




Sweden







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Bimprocil vet


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




The Netherlands







Intervet Nederland B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




Netherlands






Depocilline, suspensie voor injectie


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, sheep, pig, dog, cat


Intramuscular, subcutaneous use




The Netherlands







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Norocillin, 300 000  I.E. per ml suspensie voor injectie


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, sheep, pig, dog, cat


Intramuscular use




The Netherlands







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Pen 30 Inj., 300 000  IE/ml, suspensie voor injectie voor varkens


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Pig


Intramuscular use




The Netherlands







Eurovet Animal Health B.V.




Handelsweg 25




5531 AE Bladel




The Netherlands






Pen 30 Pro Inj., suspensie voor injectie


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Dog, cat


Intramuscular use




The Netherlands







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Penject 30, 300 000  IE/ml, suspensie voor injectie voor varkens


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Pig


Intramuscular use




The Netherlands







Kepro B.V.




Maagdenburgstraat 17




7421 ZA Deventer




The Netherlands






P.P. 30 % Susp. Pro Inj., suspensie voor injectie voor honden en katten


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Dog, cat


Intramuscular use




The Netherlands







Dopharma Research B.V.




Zalmweg 24




4941 VX Raamsdonksveer




The Netherlands






Procpen 30, 300 000  I.E. per ml suspensie voor injectie


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Cattle, sheep, pig, dog, cat


Intramuscular use




The Netherlands







Alfasan Nederland B.V.




Kuipersweg 9




3449 JA Woerden




The Netherlands






Procaine penicilline ‘30’ Pro Inj, 300 000  IE/ml, suspensie voor injectie voor hond en kat


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Dog, cat


Intramuscular use




The Netherlands







Alfasan Nederland B.V.




Kuipersweg 9




3449 JA Woerden




The Netherlands






Procaine Penicilline ‘30’ Pro Inj, 300 000  IE/ml, suspensie voor injectie


Procaine benzylpenicillin


300 000 IU/ml


Suspension for injection


Pig, piglet, dog, cat


Intramuscular use




The Netherlands







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig (> 25 kg)


Intramuscular use




The Netherlands







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






Procipen 300 mg/ml suspensie voor injectie voor runderen, schapen en varkens


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




The Netherlands







aniMedica GmbH




Im Südfeld 9




48308 Senden-Bösensell




Germany






Procapen, 300 mg/ml, suspensie voor injectie voor runderen, varkens en paarden


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




UK (Northern Ireland)







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




UK (Northern Ireland)







MSD Animal Health UK Limited




Walton Manor




Walton, Milton Keynes




MK7 7AJ




United Kingdom






Depocillin 300 mg/ml suspension for injection


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, sheep, pig, dog, cat


Intramuscular, subcutaneous use




UK (Northern Ireland)







Norbrook Laboratories Limited




Rosmore Industrial Estate, H18 W620,




Monaghan




Ireland






Norocillin 30 % w/v suspension for injection


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




UK (Northern Ireland)







Fatro S.p.A.,




Via Emilia, 285,




40064 Ozzano d'Emilia, Bologna,




Italy






Primopen 300 mg/ml suspension for injection for cattle, pigs and horses


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, horse, pig


Intramuscular use




UK (Northern Ireland)







Laboratorios Syva, S.A.U.




Avda. Párroco Pablo Diez, 49-57




24010 Leon




Spain






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, pig


Intramuscular use




UK (Northern Ireland)







Bimeda Animal Health Limited




2, 3 & 4 Airton Close




Airton Road, Tallaght




Dublin 24




Ireland






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


Procaine benzylpenicillin


300 mg/ml


Suspension for injection


Cattle, sheep, pig


Intramuscular use




UK (Northern Ireland)







Norbrook Laboratories Limited




Rosmore Industrial Estate,




H18 W620, Monaghan




Ireland






Ultrapen LA 30 % suspension for injection


Procaine benzylpenicillin


30 % w/v


Suspension for injection


Cattle, pig


Intramuscular, subcutaneous use







ELI: http://data.europa.eu/eli/C/2024/911/oj
ISSN 1977-091X (electronic edition)