Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2021 to 31 July 2021 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)
Date: 2021-08-27
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_2021346EN.01001401.xml










27.8.2021   


EN


Official Journal of the European Union


C 346/14






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2021 to 31 July 2021
(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))
(2021/C 346/03)
—   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




13.7.2021


Modified live porcine respiratory and reproductive syndrome (PRRS) virus vaccines


Porcine respiratory and reproductive syndrome virus vaccine (live)


See Annex


See Annex


14.7.2021






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.




ANNEX
List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, routes of administration, marketing authorisation holder(s) in the Member States












Member State EU/EEA


Marketing authorisation holder


Name


INN


Strength


Pharmaceutical form


Animal species


Route of administration




Austria







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50
 (1)



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Austria







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50
 (2)



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Austria







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Austria







Intervet GmbH




Siemensstraße 107




1210 Vienna




Austria






Porcilis PRRS, Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Austria







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU Lyophilisat und Lösungsmittel zur Herstellung einer Injektionssuspension für Schweine


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Belgium







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Belgium







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU & ImpranFLEX


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Belgium







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Belgium







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Belgium







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS Modified Live Virus


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Belgium







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Bulgaria







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Bulgaria







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Bulgaria







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU Lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Bulgaria







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS Lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Croatia







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS, liofilizat i otapalo za suspenziju za injekciju, za svinje


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Croatia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU, liofilizat i otapalo za suspenziju za injekciju, za svinje


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Croatia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU, liofilizat i otapalo za suspenziju za injekciju, za svinje


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Croatia







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac, liofilizat i otapalo za suspenziju za injekciju, za svinje


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Croatia







Intervet International B.V., Podružnica u Republici Hrvatskoj,




Ivana Lučića 2a,




10000 Zagreb,




Croatia






PORCILIS PRRS, liofilizat i diluent za injekcijsku suspenziju, svinja


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Cyprus







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU λυοφιλοποιημένη σκόνη και Ingelvac PRRSFLEX EU διαλύτης για ενέσιμο εναιώρημα για χοίρους.


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Cyprus







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






PERSOVAC λυοφιλοποιημένο υλικό και διαλύτης για ενέσιμο εναιώρημα για χοίρους


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Cyprus







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






PORCILIS PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Cyprus







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU λυοφιλοποιημένο υλικό και ImpranFLEX διαλύτης για ενέσιμο εναιώρημα για χοίρους


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Cyprus







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS λυοφιλοποιημένη κόνις και διαλύτης για ενέσιμο εναιώρημα για χοίρους


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Czechia







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS lyofilizát a rozpouštědlo pro injekční suspenzi pro prasata


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Czechia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU lyofilizát a rozpouštědlo pro injekční suspenzi pro prasata


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Czechia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU lyofilizát a rozpouštědlo pro injekční suspenzi pro prasata


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Czechia







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac lyophilisate and solvent for suspension for injection for pigs


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Czechia







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS lyofilizát pro přípravu injekční suspenze s rozpouštědlem


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Czechia







Bioveta, a. s.




Komenského 212/12




683 23 Ivanovice na Hané




Czech Republic






BIOSUIS PRRS live lyofilizát a rozpouštědlo pro injekční suspenzi


Live attenuated PRRS virus, strain BIO 60 — EU


103.4–106.8 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Denmark







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS Vet.


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Denmark







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS Vet.


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Denmark







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Estonia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Estonia







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Estonia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Estonia







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




France







Intervet




Rue Olivier de Serres




Angers Technopole




49071 Beaucouze Cedex




France






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




France







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS lyophilisat et solvant pour suspension injectable pour porcins


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




France







Boehringer Ingelheim Animal Health France




29 avenue Tony Garnier




69007 Lyon




France






Ingelvac PRRSFLEX EU lyophilisat et Ingelvac PRRSFLEX EU solvant pour suspension injectable pour porcins


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




France







Boehringer Ingelheim Animal Health France




29 avenue Tony Garnier




69007 Lyon




France






ReproCyc PRRS EU lyophilisat et ImpranFLEX solvant pour suspension injectable pour porcins


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




France







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac lyophilisat et solvant pour suspension injectable pour porcins


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Germany







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Germany







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS MLV


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Germany







Ceva Tiergesundheit GmbH




Kanzlerstr. 4




40472 Düsseldorf




Germany






Persovac


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Germany







Intervet Deutschland GmbH




Feldstraße 1a




85716 Unterschleissheim




Germany






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Germany







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Germany







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Greece







Intervet Hellas




63 Agiou Dimitriou St.,




17456, Alimos, Athens




Greece






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Greece







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Greece







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Greece







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Hungary







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU vakcina A.U.V.


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Hungary







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac vakcina A.U.V.


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Hungary







Intervet Hungaria Kft.




Budapest, Lechner Odon fasor 8., 1095,




Hungary






Porcilis PRRS vakcina A.U.V.


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Hungary







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU vakcina A.U.V.


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Hungary







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS vakcina A.U.V


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Ireland







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Ireland







Intervet Ireland Limited Magna Drive Magna Business Park, Citywest Road,




Dublin 24,




Ireland






Porcilis PRRS lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Ireland







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Ireland







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Italy







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU liofilizzato e Ingelvac PRRSFLEX EU solvente per sospensione iniettabile per suini


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Italy







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac liofilizzato e diluente per sospensione iniettabile per suini


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Italy







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU liofilizzato e ReproCyc PRRS EU solvente per sospensione iniettabile per suini


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Italy







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porsilis PRRS liofilizzato e solvente per sospensione iniettabile per suini


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Latvia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU liofilizāts un šķīdinātājs suspensijas injekcijām pagatavošanai cūkām


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Latvia







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac liofilizāts un šķīdinātājs suspensijas injekcijām pagatavošanai cūkām


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Latvia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU liofilizāts un šķīdinātājs suspensijas injekcijām pagatavošanai cūkām


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Latvia







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS liofilizāts un šķīdinātājs suspensijas injekcijām pagatavošanai cūkām


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Latvia







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS liofilizāts un šķīdinātājs suspensijas injekcijām pagatavošanai cūkām


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Lithuania







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






INGELVAC PRRS MLV, gyva liofilizuota vakcina ir skiediklis


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Lithuania







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU, liofilizatas ir skiediklis injekcinei suspensijai ruošti kiaulėms


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Lithuania







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU, liofilizatas ir skiediklis injekcinei suspensijai ruošti kiaulėms


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Lithuania







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS, liofilizatas ir skiediklis injekcinei suspensijai ruošti kiaulėms


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Lithuania







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




Nyderlanda






Porcilis PRRS, liofilizatas ir skiediklis injekcinei suspensijai kiaulėms


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Luxembourg







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS
lyophilisat et solvant pour suspension injectable


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Luxembourg







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU & ImpranFLEX


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Luxembourg







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Luxembourg







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Luxembourg







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS Modified Live Virus


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Luxembourg







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Malta







Intervet Ireland ltd., Magna Drive, Magna Business Park City, Dublin 24,




Ireland






Porcilis PRRS lyophilisate and solvent for suspension for injection for pigs


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Malta







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Poland







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Poland







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Poland







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Poland







Ceva Animal Health Polska Sp. z o.o.




ul. Okrzei 1A




03-715 Warsaw




Poland






Persovac


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Poland







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS MLV


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Portugal







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU liofilizado e solvente para suspensão injetável para suínos


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Portugal







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS MLV liofilizado e solvente para suspensão injetável para suínos


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Portugal







Ceva Saúde Animal — Produtos Farmacêuticos e Imunológicos, Lda.




Rua Doutor António Loureiro Borges, 9/9A, 9oA




Miraflores- 1495-131 Algés




Portugal






Persovac liofilizado e solvente para suspensão injetável para suínos


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Portugal







MSD Animal Health Lda.




Edifício Vasco da Gama, n.o 19




Quinta da Fonte, Porto Salvo




2770 192 Paço de Arcos




Portugal






Porcilis PRRS liofilizado e solvente para suspensão injetável para suínos


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Portugal







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU liofilizado e solvente para suspensão injetável para suínos


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Portugal







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






UNISTRAIN PRRS liofilizado e solvente para suspensão injetável para suínos


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Romania







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Romania







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Romania







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Romania







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Slovenia







CEVA-Phylaxia Veterinary Biologicals Co. Ltd.




Szállás Utca 5




1107 Budapest




Hungary






Persovac liofilizat in vehikel za suspenzijo za injiciranje za prašiče


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Slovenia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU liofilizat in vehikel za suspenzijo za injiciranje za prašiče


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Slovenia







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS liofilizat in vehikel za suspenzijo za injiciranje za prašiče


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Slovenia







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS liofilizat in topilo za raztopino za injiciranje za prašiče


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Slovenia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU liofilizat in vehikel za suspenzijo za injiciranje za prašiče


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Slovakia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU lyofilizát a rozpúšťadlo na injekčnú suspenziu pre ošípané


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Slovakia







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS lyofilizát a rozpúšťadlo na injekčnú suspenziu pre ošípané


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Slovakia







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU lyofilizát a rozpúšťadlo na injekčnú suspenziu pre ošípané


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Slovakia







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS lyofilizát a rozpúšťadlo na injekčnú suspenziu pre ošípané


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal 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






Porcilis PRRS, liofilizado y disolvente para suspensión inyectable para porcino


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Spain







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS liofilizado y disolvente para suspensión inyectable para porcino.


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




Spain







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU, liofilizado y disolvente para suspensión inyectable para porcino


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Spain







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU, liofilizado y disolvente para suspensión inyectable para porcino


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Spain







Ceva Salud Animal, S.A.




Avenida Diagonal 609-615




08028 Barcelona




Spain






Persovac liofilizado y disolvente para suspensión inyectable para porcino


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Spain







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS MLV


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Spain







Laboratorios Syva, S.A.U.,




Avda. Parroco Pablo Diez, 49-57, San Andres Del Rabanedo, 24010 Leon, Spain






Pyrsvac-183


Live attenuated PRRS virus, strain ALL 183


min. 105 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




Spain







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Amervac PRRS


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




The Netherlands







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






ReproCyc PRRS EU, lyofilisaat en suspendeervloeistof voor suspensie voor injectie voor varkens


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




The Netherlands







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRS MLV


Live attenuated PRRS virus, strain VR 2332


min. 104.9 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




The Netherlands







Kernfarm B.V.




De Corridor 14 d Breukelen




3621 ZB




The Netherlands






Ingelvac PRRSFLEX EU, Lyofilisaat en suspendeervloeistof voor suspensie voor injectie voor varkens


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




The Netherlands







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173




55216 Ingelheim am Rhein




Germany






Ingelvac PRRSFLEX EU, lyofilisaat en suspendeervloeistof voor suspensie voor injectie voor varkens


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




The Netherlands







Intervet International B.V.




Wim de Körverstraat 35




Boxmeer 5831 AN




The Netherlands






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




The Netherlands







Kernfarm B.V.




De Corridor 14D




Breukelen 3621 ZB




The Netherlands






Porcilis PRRS


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




The Netherlands







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS lyofilisaat en suspendeervloeistof voor suspensie voor injectie bij varkens


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




United Kingdom (Northern Ireland) (3)








Boehringer Ingelheim Animal Health UK Ltd




Ellesfield Avenue




Bracknell RG12 8YS




United Kingdom






Ingelvac PRRSFLEX EU Lyophilisate and Solvent for Suspension for Injection for Pigs


Live attenuated PRRS virus, strain 94881 (genotype 1)


104.4-106.6 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




United Kingdom (Northern Ireland)







Ceva Animal Health Ltd




Unit 3, Anglo Office Park




White Lion Road




Amersham HP7 9FB




United Kingdom






Persovac lyophilisate and solvent for suspension for injection for pigs


Live PRRS virus, strain P120


104.0–107.3 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




United Kingdom (Northern Ireland)







Intervet UK Ltd




Walton Manor




Walton




Milton Keynes MK7 7AJ




United Kingdom






Porcilis PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs


Live attenuated PRRS virus, strain DV


104.0-106.3 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use




United Kingdom (Northern Ireland)







Boehringer Ingelheim Animal Health UK Ltd




Ellesfield Avenue




Bracknell RG12 8YS




United Kingdom






ReproCyc PRRS EU Lyophilisate and Solvent for Suspension for Injection for Pigs


Live attenuated PRRS virus, strain 94881 (genotype 1)


103.9-107.0 TCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use




United Kingdom (Northern Ireland)







Laboratorios Hipra, S.A.




Avda. la Selva, 135




17170 Amer (Girona)




Spain






Unistrain PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs


Live attenuated PRRS virus, strain VP-046 BIS


103.5-105.5 CCID50



Lyophilisate and solvent for suspension for injection


Pigs


Intramuscular use
Intradermal use






(1)  Cell culture infectious dose 50 %.

(2)  Tissue culture infectious dose 50 %.

(3)  For the United Kingdom, as from 1 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.