# C_2021346EN.01001401.xml

| 27.8.2021 | EN | Official Journal of the European Union | C 346/14 |
| --- | --- | --- | --- |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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.

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