# Official Journal C 369/2019

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 369 |
| | |
| English edition | Information and Notices | Volume 6230 October 2019 |

ISSN 1977-091X

Official Journal

of the European Union

C 369

English edition

Information and Notices

Volume 6230 October 2019

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| Contents | page |
| --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2019/C 369/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| 2019/C 369/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 11 |

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2019/C 369/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

1

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

2019/C 369/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

11

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| EN | |
| --- | --- |

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 30.10.2019 | EN | Official Journal of the European Union | C 369/1 |
| --- | --- | --- | --- |

30.10.2019

EN

Official Journal of the European Union

C 369/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)

  )

(2019/C 369/01)

| — | Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 19.9.2019 | Epidyolex | cannabidiol | GW Pharma (International) B.V.
  Amersfoort A1, Databankweg 26, 3821AL Amersfoort, Nederland | EU/1/19/1389 | Oral solution | N03AX24 | 23.9.2019 |
| 19.9.2019 | Inbrija | levodopa | Acorda Therapeutics Ireland Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | EU/1/19/1390 | Inhalation powder, hard capsule | N04BA01 | 23.9.2019 |
| 19.9.2019 | VITRAKVI | larotrectinib | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/19/1385 | Capsule, hard
  Oral solution | L01XE53 | 23.9.2019 |
| 26.9.2019 | Deferasirox Mylan | deferasirox | Mylan S.A.S.
  117 allée des Parcs, 69800 Saint Priest, France | EU/1/19/1386 | Film-coated tablet | V03AC03 | 30.9.2019 |
| 26.9.2019 | Trogarzo | ibalizumab | Theratechnologies International Limited
  10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland | EU/1/19/1359 | Concentrate for solution for infusion | J05AX23 | 30.9.2019 |
| 27.9.2019 | NUCEIVA | botulinum toxin type A | Evolus Pharma Limited
  70 Sir John Rogerson's Quay, Dublin 2, Ireland | EU/1/19/1364 | Powder for solution for injection | M03AX01 | 1.10.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

19.9.2019

Epidyolex

cannabidiol

GW Pharma (International) B.V.

Amersfoort A1, Databankweg 26, 3821AL Amersfoort, Nederland

EU/1/19/1389

Oral solution

N03AX24

23.9.2019

19.9.2019

Inbrija

levodopa

Acorda Therapeutics Ireland Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/19/1390

Inhalation powder, hard capsule

N04BA01

23.9.2019

19.9.2019

VITRAKVI

larotrectinib

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/19/1385

Capsule, hard

Oral solution

L01XE53

23.9.2019

26.9.2019

Deferasirox Mylan

deferasirox

Mylan S.A.S.

117 allée des Parcs, 69800 Saint Priest, France

EU/1/19/1386

Film-coated tablet

V03AC03

30.9.2019

26.9.2019

Trogarzo

ibalizumab

Theratechnologies International Limited

10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland

EU/1/19/1359

Concentrate for solution for infusion

J05AX23

30.9.2019

27.9.2019

NUCEIVA

botulinum toxin type A

Evolus Pharma Limited

70 Sir John Rogerson's Quay, Dublin 2, Ireland

EU/1/19/1364

Powder for solution for injection

M03AX01

1.10.2019

| — | Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2019 | AMGLIDIA | AMMTeK
  55 rue de Turbigo, 75003 Paris, France | EU/1/18/1279 | 5.9.2019 |
| 3.9.2019 | Clopidogrel Zentiva | Zentiva, k.s.
  U Kabelovny 130, 10 237 Praha 10, Česká republika | EU/1/08/465 | 5.9.2019 |
| 3.9.2019 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 5.9.2019 |
| 3.9.2019 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, 75008 Paris, France | EU/1/10/619 | 5.9.2019 |
| 3.9.2019 | Emtricitabine/Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 10 237 Praha 10, Česká republika | EU/1/16/1148 | 5.9.2019 |
| 3.9.2019 | GILENYA | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/11/677 | 5.9.2019 |
| 3.9.2019 | Lonsurf | Les Laboratoires Servier
  50 rue Carnot, 92284 Suresnes CEDEX, France | EU/1/16/1096 | 5.9.2019 |
| 3.9.2019 | Lucentis | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/06/374 | 5.9.2019 |
| 3.9.2019 | Pramipexole Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/490 | 5.9.2019 |
| 3.9.2019 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/494 | 5.9.2019 |
| 3.9.2019 | Suliqua | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/16/1157 | 5.9.2019 |
| 3.9.2019 | Sylvant | EUSA Pharma (Netherlands) B.V.
  Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland | EU/1/14/928 | 5.9.2019 |
| 3.9.2019 | Tecentriq | Roche Registration GmbH
  Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland | EU/1/17/1220 | 5.9.2019 |
| 6.9.2019 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/14/945 | 10.9.2019 |
| 6.9.2019 | Pylobactell | Torbet Laboratories Ireland Limited
  20 Holles Street, Dublin 2, Ireland | EU/1/98/064 | 10.9.2019 |
| 6.9.2019 | Rasagiline ratiopharm | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/977 | 10.9.2019 |
| 9.9.2019 | Fexeric | Akebia Europe Limited c/o Matheson, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/15/1039 | 11.9.2019 |
| 9.9.2019 | Kovaltry | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/15/1076 | 11.9.2019 |
| 13.9.2019 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 17.9.2019 |
| 13.9.2019 | Kyntheum | Leo Pharma A/S
  Industriparken 55, 2750 Ballerup, Danmark | EU/1/16/1155 | 17.9.2019 |
| 13.9.2019 | Levetiracetam Actavis Group | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/738 | 17.9.2019 |
| 13.9.2019 | Opatanol | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/02/217 | 17.9.2019 |
| 13.9.2019 | Prepandrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/08/453 | 17.9.2019 |
| 13.9.2019 | Rapamune | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/01/171 | 17.9.2019 |
| 13.9.2019 | Sivextro | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/15/991 | 17.9.2019 |
| 13.9.2019 | Twinrix Adult | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/96/020 | 17.9.2019 |
| 13.9.2019 | Twinrix Paediatric | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/97/029 | 17.9.2019 |
| 16.9.2019 | Champix | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/06/360 | 18.9.2019 |
| 16.9.2019 | Cosentyx | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/14/980 | 18.9.2019 |
| 16.9.2019 | Elonva | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/609 | 18.9.2019 |
| 16.9.2019 | Fertavid | Merck Sharp & Dohme B.V.
  Waarderweg 39, 2031 BN Haarlem, Nederland | EU/1/09/510 | 18.9.2019 |
| 16.9.2019 | Inflectra | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/13/854 | 18.9.2019 |
| 16.9.2019 | Laventair Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/899 | 18.9.2019 |
| 16.9.2019 | Lymphoseek | Norgine B.V.
  Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland | EU/1/14/955 | 18.9.2019 |
| 16.9.2019 | Mepsevii | Ultragenyx Germany GmbH
  Friedrichstraße 191, 10117 Berlin, Deutschland | EU/1/18/1301 | 18.9.2019 |
| 16.9.2019 | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | 18.9.2019 |
| 16.9.2019 | Nivestim | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/10/631 | 18.9.2019 |
| 16.9.2019 | Olumiant | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | 18.9.2019 |
| 16.9.2019 | Pregabalin Zentiva | Zentiva, k.s.
  U Kabelovny 130, 10 237 Praha 10, Česká republika | EU/1/15/1021 | 18.9.2019 |
| 16.9.2019 | Remsima | Celltrion Healthcare Hungary Kft.
  Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország | EU/1/13/853 | 18.9.2019 |
| 16.9.2019 | Riximyo | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1184 | 18.9.2019 |
| 16.9.2019 | Somavert | Pfizer Europe MA EEIG
  Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België | EU/1/02/240 | 18.9.2019 |
| 16.9.2019 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/08/494 | 18.9.2019 |
| 16.9.2019 | Tenofovir disoproxil Zentiva | Zentiva, k.s.
  U Kabelovny 130, 10 237 Praha 10, Česká republika | EU/1/16/1127 | 18.9.2019 |
| 19.9.2019 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 23.9.2019 |
| 19.9.2019 | Anoro Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/898 | 23.9.2019 |
| 19.9.2019 | Ganfort | Allergan Pharmaceuticals Ireland
  Castlebar Road, Westport, County Mayo, Ireland | EU/1/06/340 | 23.9.2019 |
| 19.9.2019 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 23.9.2019 |
| 19.9.2019 | Lysodren | HRA Pharma Rare Diseases
  200 avenue de Paris, 92 320 Chatillon, France | EU/1/04/273 | 23.9.2019 |
| 19.9.2019 | Multaq | Sanofi-Aventis groupe
  54 rue La Boétie, 75008 Paris, France | EU/1/09/591 | 23.9.2019 |
| 19.9.2019 | Tegsedi | Akcea Therapeutics Ireland Ltd
  Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland | EU/1/18/1296 | 23.9.2019 |
| 19.9.2019 | Tyverb | Novartis Europharm Limited
  Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland | EU/1/07/440 | 23.9.2019 |
| 19.9.2019 | Viekirax | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/982 | 23.9.2019 |
| 19.9.2019 | Xadago | Zambon S.p.A.
  Via Lillo del Duca 10, 20 091 Bresso (MI), Italia | EU/1/14/984 | 23.9.2019 |
| 23.9.2019 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 25.9.2019 |
| 23.9.2019 | BYDUREON | AstraZeneca AB
  15 185 Södertälje, Sverige | EU/1/11/696 | 25.9.2019 |
| 23.9.2019 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, 2340 Beerse, België | EU/1/96/011 | 25.10.2019 |
| 23.9.2019 | Ciambra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/15/1055 | 25.9.2019 |
| 23.9.2019 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstraße 1, 85748 Garching, Deutschland | EU/1/16/1105 | 25.9.2019 |
| 23.9.2019 | Epclusa | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/16/1116 | 25.9.2019 |
| 23.9.2019 | Hyrimoz | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/18/1286 | 25.9.2019 |
| 23.9.2019 | Incruse Ellipta | GlaxoSmithKline (Ireland) Limited
  12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/14/922 | 25.9.2019 |
| 23.9.2019 | Moventig | Kyowa Kirin Holdings B.V.
  Bloemlaan 2, 2132 NP Hoofddorp, Nederland | EU/1/14/962 | 25.9.2019 |
| 23.9.2019 | Myalepta | Aegerion Pharmaceuticals B.V.
  Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland | EU/1/18/1276 | 25.9.2019 |
| 23.9.2019 | Ofev | Boehringer Ingelheim International GmbH
  Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland | EU/1/14/979 | 25.9.2019 |
| 23.9.2019 | Parsabiv | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/16/1142 | 25.9.2019 |
| 23.9.2019 | Rixathon | Sandoz GmbH
  Biochemiestrasse 10, 6250 Kundl, Österreich | EU/1/17/1185 | 25.9.2019 |
| 23.9.2019 | Saxenda | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/15/992 | 25.9.2019 |
| 23.9.2019 | Thyrogen | Genzyme Europe B.V.
  Paasheuvelweg 25, 1105 BP Amsterdam, Nederland | EU/1/99/122 | 25.9.2019 |
| 23.9.2019 | Tolura | Krka d. d., Novo mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632 | 25.9.2019 |
| 23.9.2019 | Vectibix | Amgen Europe B.V.
  Minervum 7061, 4817 ZK Breda, Nederland | EU/1/07/423 | 25.9.2019 |
| 26.9.2019 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/957 | 30.9.2019 |
| 26.9.2019 | Exviera | AbbVie Deutschland GmbH & Co. KG
  Knollstrasse, 67061 Ludwigshafen, Deutschland | EU/1/14/983 | 30.9.2019 |
| 26.9.2019 | OPDIVO | Bristol-Myers Squibb Pharma EEIG
  Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland | EU/1/15/1014 | 30.9.2019 |
| 26.9.2019 | Rolufta Ellipta | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | 30.9.2019 |
| 26.9.2019 | Vosevi | Gilead Sciences Ireland UC
  Carrigtohill, County Cork, T45 DP77, Ireland | EU/1/17/1223 | 30.9.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2019

AMGLIDIA

AMMTeK

55 rue de Turbigo, 75003 Paris, France

EU/1/18/1279

5.9.2019

3.9.2019

Clopidogrel Zentiva

Zentiva, k.s.

U Kabelovny 130, 10 237 Praha 10, Česká republika

EU/1/08/465

5.9.2019

3.9.2019

Cosentyx

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/980

5.9.2019

3.9.2019

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, 75008 Paris, France

EU/1/10/619

5.9.2019

3.9.2019

Emtricitabine/Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 10 237 Praha 10, Česká republika

EU/1/16/1148

5.9.2019

3.9.2019

GILENYA

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/11/677

5.9.2019

3.9.2019

Lonsurf

Les Laboratoires Servier

50 rue Carnot, 92284 Suresnes CEDEX, France

EU/1/16/1096

5.9.2019

3.9.2019

Lucentis

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/06/374

5.9.2019

3.9.2019

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

5.9.2019

3.9.2019

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

5.9.2019

3.9.2019

Suliqua

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/16/1157

5.9.2019

3.9.2019

Sylvant

EUSA Pharma (Netherlands) B.V.

Johannes Vermeerplein 11, 1071 DV Amsterdam, Nederland

EU/1/14/928

5.9.2019

3.9.2019

Tecentriq

Roche Registration GmbH

Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland

EU/1/17/1220

5.9.2019

6.9.2019

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/14/945

10.9.2019

6.9.2019

Pylobactell

Torbet Laboratories Ireland Limited

20 Holles Street, Dublin 2, Ireland

EU/1/98/064

10.9.2019

6.9.2019

Rasagiline ratiopharm

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/977

10.9.2019

9.9.2019

Fexeric

Akebia Europe Limited c/o Matheson, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/15/1039

11.9.2019

9.9.2019

Kovaltry

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1076

11.9.2019

13.9.2019

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

17.9.2019

13.9.2019

Kyntheum

Leo Pharma A/S

Industriparken 55, 2750 Ballerup, Danmark

EU/1/16/1155

17.9.2019

13.9.2019

Levetiracetam Actavis Group

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/738

17.9.2019

13.9.2019

Opatanol

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/02/217

17.9.2019

13.9.2019

Prepandrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/08/453

17.9.2019

13.9.2019

Rapamune

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/01/171

17.9.2019

13.9.2019

Sivextro

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/15/991

17.9.2019

13.9.2019

Twinrix Adult

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/96/020

17.9.2019

13.9.2019

Twinrix Paediatric

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/97/029

17.9.2019

16.9.2019

Champix

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/06/360

18.9.2019

16.9.2019

Cosentyx

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/14/980

18.9.2019

16.9.2019

Elonva

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/609

18.9.2019

16.9.2019

Fertavid

Merck Sharp & Dohme B.V.

Waarderweg 39, 2031 BN Haarlem, Nederland

EU/1/09/510

18.9.2019

16.9.2019

Inflectra

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/13/854

18.9.2019

16.9.2019

Laventair Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/899

18.9.2019

16.9.2019

Lymphoseek

Norgine B.V.

Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland

EU/1/14/955

18.9.2019

16.9.2019

Mepsevii

Ultragenyx Germany GmbH

Friedrichstraße 191, 10117 Berlin, Deutschland

EU/1/18/1301

18.9.2019

16.9.2019

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

18.9.2019

16.9.2019

Nivestim

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/10/631

18.9.2019

16.9.2019

Olumiant

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

18.9.2019

16.9.2019

Pregabalin Zentiva

Zentiva, k.s.

U Kabelovny 130, 10 237 Praha 10, Česká republika

EU/1/15/1021

18.9.2019

16.9.2019

Remsima

Celltrion Healthcare Hungary Kft.

Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország

EU/1/13/853

18.9.2019

16.9.2019

Riximyo

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1184

18.9.2019

16.9.2019

Somavert

Pfizer Europe MA EEIG

Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België

EU/1/02/240

18.9.2019

16.9.2019

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/08/494

18.9.2019

16.9.2019

Tenofovir disoproxil Zentiva

Zentiva, k.s.

U Kabelovny 130, 10 237 Praha 10, Česká republika

EU/1/16/1127

18.9.2019

19.9.2019

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

23.9.2019

19.9.2019

Anoro Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/898

23.9.2019

19.9.2019

Ganfort

Allergan Pharmaceuticals Ireland

Castlebar Road, Westport, County Mayo, Ireland

EU/1/06/340

23.9.2019

19.9.2019

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

23.9.2019

19.9.2019

Lysodren

HRA Pharma Rare Diseases

200 avenue de Paris, 92 320 Chatillon, France

EU/1/04/273

23.9.2019

19.9.2019

Multaq

Sanofi-Aventis groupe

54 rue La Boétie, 75008 Paris, France

EU/1/09/591

23.9.2019

19.9.2019

Tegsedi

Akcea Therapeutics Ireland Ltd

Regus House, Harcourt Centre, Harcourt Road, Dublin 2, Ireland

EU/1/18/1296

23.9.2019

19.9.2019

Tyverb

Novartis Europharm Limited

Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland

EU/1/07/440

23.9.2019

19.9.2019

Viekirax

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/982

23.9.2019

19.9.2019

Xadago

Zambon S.p.A.

Via Lillo del Duca 10, 20 091 Bresso (MI), Italia

EU/1/14/984

23.9.2019

23.9.2019

APTIVUS

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/05/315

25.9.2019

23.9.2019

BYDUREON

AstraZeneca AB

15 185 Södertälje, Sverige

EU/1/11/696

25.9.2019

23.9.2019

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, 2340 Beerse, België

EU/1/96/011

25.10.2019

23.9.2019

Ciambra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/15/1055

25.9.2019

23.9.2019

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstraße 1, 85748 Garching, Deutschland

EU/1/16/1105

25.9.2019

23.9.2019

Epclusa

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/16/1116

25.9.2019

23.9.2019

Hyrimoz

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/18/1286

25.9.2019

23.9.2019

Incruse Ellipta

GlaxoSmithKline (Ireland) Limited

12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/14/922

25.9.2019

23.9.2019

Moventig

Kyowa Kirin Holdings B.V.

Bloemlaan 2, 2132 NP Hoofddorp, Nederland

EU/1/14/962

25.9.2019

23.9.2019

Myalepta

Aegerion Pharmaceuticals B.V.

Atrium Building, 8th Floor, Strawinskylaan 3127, 1077 ZX Amsterdam, Nederland

EU/1/18/1276

25.9.2019

23.9.2019

Ofev

Boehringer Ingelheim International GmbH

Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland

EU/1/14/979

25.9.2019

23.9.2019

Parsabiv

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/16/1142

25.9.2019

23.9.2019

Rixathon

Sandoz GmbH

Biochemiestrasse 10, 6250 Kundl, Österreich

EU/1/17/1185

25.9.2019

23.9.2019

Saxenda

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/15/992

25.9.2019

23.9.2019

Thyrogen

Genzyme Europe B.V.

Paasheuvelweg 25, 1105 BP Amsterdam, Nederland

EU/1/99/122

25.9.2019

23.9.2019

Tolura

Krka d. d., Novo mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632

25.9.2019

23.9.2019

Vectibix

Amgen Europe B.V.

Minervum 7061, 4817 ZK Breda, Nederland

EU/1/07/423

25.9.2019

26.9.2019

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

30.9.2019

26.9.2019

Exviera

AbbVie Deutschland GmbH & Co. KG

Knollstrasse, 67061 Ludwigshafen, Deutschland

EU/1/14/983

30.9.2019

26.9.2019

OPDIVO

Bristol-Myers Squibb Pharma EEIG

Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland

EU/1/15/1014

30.9.2019

26.9.2019

Rolufta Ellipta

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

30.9.2019

26.9.2019

Vosevi

Gilead Sciences Ireland UC

Carrigtohill, County Cork, T45 DP77, Ireland

EU/1/17/1223

30.9.2019

| — | Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.9.2019 | Iblias | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/15/1077 | 5.9.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

3.9.2019

Iblias

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/15/1077

5.9.2019

| — | Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.9.2019 | Simparica Trio | sarolaner / moxidectin / pyrantel embonate | Zoetis Belgium S.A.
  rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/19/243 | Chewable tablet | QP54AB52 | 19.9.2019 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

17.9.2019

Simparica Trio

sarolaner / moxidectin / pyrantel embonate

Zoetis Belgium S.A.

rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/19/243

Chewable tablet

QP54AB52

19.9.2019

| — | Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.9.2019 | RESPIPORC FLUpan H1N1 | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/209 | 10.9.2019 |
| 13.9.2019 | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/14/175 | 17.9.2019 |
| 20.9.2019 | Cepedex | CP-Pharma Handelsgesellschaft mbH
  Ostlandring 13, 31303 Burgdorf, Deutschland | EU/2/16/200 | 24.9.2019 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

6.9.2019

RESPIPORC FLUpan H1N1

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/209

10.9.2019

13.9.2019

Porcilis PCV M Hyo

Intervet International B.V.

Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/14/175

17.9.2019

20.9.2019

Cepedex

CP-Pharma Handelsgesellschaft mbH

Ostlandring 13, 31303 Burgdorf, Deutschland

EU/2/16/200

24.9.2019

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| European Medicines Agency |
| --- |
| Domenico Scarlattilaan 6 |
| 1083 HS Amsterdam |
| The Netherlands |

European Medicines Agency

Domenico Scarlattilaan 6

1083 HS Amsterdam

The Netherlands

---

(1)  OJ L 136, 30.4.2004, p. 1.

---

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

| 30.10.2019 | EN | Official Journal of the European Union | C 369/11 |
| --- | --- | --- | --- |

30.10.2019

EN

Official Journal of the European Union

C 369/11

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2019 to 30 September 2019

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
   or Article 38 of Directive 2001/82/EC (2)

  )

(2019/C 369/02)

| — | Issuing, maintenance or modification of a national marketing authorization |
| --- | --- |

—

Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 9.9.2019 | Bacterial lysates-containing medicinal products for respiratory conditions | Bacterial lysates containing medicinal products for respiratory conditions | See Annex I | See Annex I | 10.9.2019 |
| 20.9.2019 | Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep | Tylosin | See Annex II | See Annex II | 23.9.2019 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

9.9.2019

Bacterial lysates-containing medicinal products for respiratory conditions

Bacterial lysates containing medicinal products for respiratory conditions

See Annex I

See Annex I

10.9.2019

20.9.2019

Veterinary medicinal products containing tylosin presented as solution for injection to be administered to sheep

Tylosin

See Annex II

See Annex II

23.9.2019

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

List of nationally authorised medicinal products

| Member State EU/EEA | Marketing authorisation holder | Invented name | INN + Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Daiichi Sankyo Austria Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Austria | Laboratorio Farmaceutico S.I.T. S.R.L. | Buccalin | Streptococcus Agalactiae 1 Giga Units Tablet, Haemophilus Influenzae 1.5 Giga Units Tablet, Staphylococcus Aureus 1 Giga Units Tablet, Streptococcus Pneumoniae 1 Giga Units Tablet | Film-Coated Tablet | Oral Use |
| Austria | Om Pharma S.A. | Broncho-Vaxom Für Erwachsene | Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7 mg Capsule | Capsule, Hard | Oral Use |
| Austria | Om Pharma S.A. | Broncho-Vaxom Für Kinder | Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Belgium | Om Pharma S.A. | Broncho Vaxom | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Belgium | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Bulgaria | Bb - Ncipd Ltd. | Respivax | Haemophilus Influenzae Type B (Hib) 0.625 Giga Cells / 25 mg, Branhamella Catarrhalis Lysate 0.625 Giga Cells / 25 mg, Klebsiella Pneumoniae (Inactivated) 0.625 Giga Cells / 25 mg, Staphylococcus Aureus Inactivated Bacteria 0.625 Giga Cells / 25 mg, Streptococcus Pneumoniae Inactivated Bacteria 0.625 Giga Cells / 25 mg, Streptococcus Pyogenes Inactivated Bacteria 0.625 Giga Cells / 25 mg | Tablet | Oral Use |
| Bulgaria | Bb - Ncipd Ltd. | Respivax | Haemophilus Influenzae Type B (Hib) 1.25 Giga Cells / 50 mg, Branhamella Catarrhalis Lysate 1.25 Giga Cells / 50 mg, Klebsiella Pneumoniae (Inactivated) 1.25 Giga Cells / 50 mg, Staphylococcus Aureus Inactivated Bacteria 1.25 Giga Cells / 50 mg, Streptococcus Pneumoniae Inactivated Bacteria 1.25 Giga Cells / 50 mg, Streptococcus Pyogenes Inactivated Bacteria 1.25 Giga Cells / 50 mg | Tablet | Oral Use |
| Bulgaria | Om Pharma S.A. | Бронхо – Ваксом За Възрастни | Standardized Lyophylisate Of Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Bulgaria | Om Pharma S.A. | Бронхо – Ваксом За Деца | Lyophilized Bacterial Lysates 3.5 mg Sachet | Granules | Oral Use |
| Bulgaria | Om Pharma S.A. | Бронхо–ваксом За Деца | Standardized Lyophylisate Of Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Bulgaria | Pierre Fabre Medicament | Рибомунил | Proteoglycanes Of Klebsiella Pneumoniae 1.125 mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70 % Rna) 0.75 mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet | Granules For Oral Solution | Oral Use |
| Czech Republic | Daiichi Sankyo Europe Gmbh | Luivac | Lysatum Bacteriale Mixtum 3 mg Tablet | Tablet | Oral Use |
| Czech Republic | Om Pharma S.A. | Broncho-Vaxom Pro Adultis | Lysatum Bacteriale Mixtum 7 mg Capsule | Capsule, Hard | Oral Use |
| Czech Republic | Om Pharma S.A. | Broncho-Vaxom Pro Infantibus | Lysatum Bacteriale Mixtum 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Czech Republic | Om Pharma S.A. | Broncho-Vaxom Pro Infantibus | Lysatum Bacteriale Mixtum 3.5 mg Sachet | Granules In Sachet | Oral Use |
| Czech Republic | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Sachet, Ribosomes Of Haemophilus Influenzae 0.5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 3 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Sachet | Granules For Oral Solution | Oral Use |
| Czech Republic | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet | Tablet | Oral Use |
| Germany | Daiichi Sankyo Europe Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Germany | Om Pharma S.A. | Broncho-Munal Erwachsene | Lyophilised, Standardised Bacterial Extract 7 mg Capsule | Capsule, Hard | Oral Use |
| Germany | Om Pharma S.A. | Broncho-Munal Kinder | Lyophilised, Standardised Bacterial Extract 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Germany | Om Pharma S.A. | Broncho-Vaxom | Lyophilised, Standardised Bacterial Extract 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Germany | Om Pharma S.A. | Broncho-Vaxom Erwachsene | Lyophilised, Standardised Bacterial Extract 7 mg Capsule | Capsule | Oral Use |
| Greece | Gap S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Greece | Gap S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Greece | Rafarm Sa. | Pir-05 | Lyophilized Bacterial Lysates 7 mg Tablet | Sublingual Tablet | Sublingual Use |
| Hungary | Om Pharma S.A. | Broncho-Vaxom Felnotteknek | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Hungary | Om Pharma S.A. | Broncho-Vaxom Gyermekeknek | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Hungary | Om Pharma S.A. | Broncho-Vaxom Gyermekeknek | Lyophilized Bacterial Lysates 3.5 mg Sachet | Powder For Oral Solution | Oral Use |
| Italy | Abiogen Pharma S.P.A. | Broncho Munal | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Italy | Abiogen Pharma S.P.A. | Broncho Munal | Lyophilized Bacterial Lysates 3.5 mg Sachet | Granules In Sachet | Oral Use |
| Italy | Abiogen Pharma S.P.A. | Broncho Munal | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Italy | Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A. | Ommunal | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Italy | Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A. | Ommunal | Lyophilized Bacterial Lysates 3.5 mg Sachet | Granules For Oral Suspension | Oral Use |
| Italy | Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A. | Ommunal | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Italy | Bruschettini S.R.L | Immubron | Glycine 43 mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Oralis 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50 mg Tablet | Sublingual Tablet | Sublingual Use |
| Italy | Bruschettini S.R.L | Lantigen B | Haemophilus Influenzae Type B (Hib) 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2dagu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml | Oral Drops, Suspension | Oral Use |
| Italy | Daiichi Sankyo Italia S.P.A | Paspat | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Italy | Laboratorio Farmaceutico S.I.T. S.R.L. | Buccalin | Streptococcus Agalactiae 1 000 Mega Units Tablet, Haemophilus Influenzae 1 500 Mega Units Tablet, Staphylococcus Aureus 1 000 Mega Units Tablet, Streptococcus Pneumoniae 1 000 Mega Units Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Laboratorio Farmaceutico S.I.T. S.R.L. | Buccalin | Streptococcus Agalactiae 1 000 Mega Units Tablet, Haemophilus Influenzae 1 500 Mega Units Tablet, Staphylococcus Aureus 1 000 Mega Units Tablet, Streptococcus Pneumoniae 1 000 Mega Units Tablet | Gastro-Resistant Tablet | Oral Use |
| Italy | Lallemand Pharma Europe | Ismigen | Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 GigaCells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Oralis 6 GigaCells Tablet | Sublingual Tablet | Sublingual Use |
| Italy | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Italy | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Sachet | Granules In Sachet | Oral Use |
| Italy | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Italy | Pierre Fabre Pharma S.R.L. | Immucytal | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Granules For Oral Solution | Oral Use |
| Italy | Pierre Fabre Pharma S.R.L. | Immucytal | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Tablet | Oral Use |
| Latvia | Daiichi Sankyo Europe Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Latvia | Lek Pharmaceuticals D.D. Ljubljana | Broncho-Munal | Bacterial Lysate 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Latvia | Lek Pharmaceuticals D.D. Ljubljana | Broncho-Munal | Bacterial Lysate 7 mg Capsule | Capsule, Hard | Oral Use |
| Lithuania | Daiichi Sankyo Europe Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Lithuania | Lek Pharmaceuticals D.D. Ljubljana | Broncho-Munal | Bacterial Lysate 7 mg Capsule | Capsule, Hard | Oral Use |
| Lithuania | Lek Pharmaceuticals D.D. Ljubljana | Broncho-Munal | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Lithuania | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Granules For Oral Solution | Oral Use |
| Lithuania | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Tablet | Oral Use |
| Luxembourg | Daiichi Sankyo Europe Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Luxembourg | Om Pharma S.A. | Broncho Vaxom | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Luxembourg | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Malta | Bruschettini S.R.L | Immubron | Glycine 43 mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Viridans 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50 mg Tablet | Sublingual Tablet | Sublingual Use |
| Malta | Bruschettini S.R.L | Lantigen B | Haemophilus Influenzae Type B (Hib) 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2 agu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml | Oral Drops, Suspension | Oral Use |
| Poland | Daiichi Sankyo Europe Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Poland | Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna | Polyvaccinum Forte | Escherichia Coli (Inactivated) 200 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 100 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 500 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 500 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 100 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 100 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 200 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 100 Mega Cells / Ml | Suspension For Injection | Intramuscular Use $ Subcutaneous Use |
| Poland | Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna | Polyvaccinum Mite | Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml | Nasal Drops, Suspension | Nasal Use |
| Poland | Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna | Polyvaccinum Mite | Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml | Suspension For Injection | Intramuscular Use $ Subcutaneous Use |
| Poland | Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna | Polyvaccinum Submite | Escherichia Coli (Inactivated) 2 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 1 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 5 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 5 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 1 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 1 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 2 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 1 Mega Cells / Ml | Suspension For Injection | Intramuscular Use $ Subcutaneous Use |
| Poland | Lallemand Pharma Europe | Ismigen | Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 Giga Cells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Viridans 6 Giga Cells Tablet | Sublingual Tablet | Sublingual Use |
| Poland | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Poland | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Sachet | Granules In Sachet | Oral Use |
| Poland | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Poland | Pierre Fabre Medicament Polska Sp. Z O.O. | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet | Tablet | Oral Use |
| Poland | Pierre Fabre Medicament Polska Sp. Z O.O. | Ribomunyl | Proteoglycanes Of Klebsiella Pneumoniae 1.125 mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70 % Rna) 0.75 mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet | Granules For Oral Solution | Oral Use |
| Poland | Pierre Fabre Medicament Polska Sp. Z O.O. | Ribomunyl | Proteoglycanes Of Klebsiella Pneumoniae 1.125 mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet | Granules For Oral Solution | Oral Use |
| Portugal | Almirall Produtos Farmacêuticos, Lda. | Provax | Diplococcus Pneumoniae Type I 6 000 Milli I.U. Tablet, Haemophilus Influenzae 6 000  Milli I.U. Tablet, Klebsiella Ozaenae 6 Milli I.U. Tablet, Klebsiella Pneumoniae 6 000  Milli I.U. Tablet, Neisseria Catarrhalis 6 000 Milli I.U. Tablet, Staphylococcus Aureus 6 000 Milli I.U. Tablet, Streptococcus Pyogenes 6 000 Milli I.U. Tablet, Streptococcus Viridans 6 000  Milli I.U. Tablet | Tablet | Oral Use |
| Portugal | Daiichi Sankyo Portugal, Unip. Lda | Paspat Oral | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Portugal | Lusomedicamenta – Sociedade Técnica Farmacêutica, Sa | Lantigen B | Haemophilus Influenzae 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2 agu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml | Oral Suspension | Sublingual Use |
| Portugal | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 3.5 mg Sachet | Granules | Oral Use |
| Portugal | Om Pharma S.A. | Broncho-Vaxom | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Portugal | Om Pharma S.A. | Broncho-Vaxom Infantil, | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Portugal | Pierre Fabre Médicament Portugal, Lda. | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet | Tablet | Oral Use |
| Portugal | Pierre Fabre Médicament Portugal, Lda. | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Granules For Oral Solution | Oral Use |
| Portugal | Pierre Fabre Médicament Portugal, Lda. | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Tablet | Oral Use |
| Romania | Alvogen Malta Operations (Row) Ltd | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Romania | Bruschettini S.R.L | Lantigen B | Haemophilus Influenzae Type B (Hib) 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2 agu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml | Oral Drops, Suspension | Oral Use |
| Romania | Daiichi Sankyo Europe Gmbh | Luivac | Bacterial Lysate 3 mg Tablet | Tablet | Oral Use |
| Romania | Om Pharma S.A. | Broncho-Vaxom Adulți | Lyophilized Bacterial Lysates 7 mg Capsule | Capsule, Hard | Oral Use |
| Romania | Om Pharma S.A. | Broncho-Vaxom Copii | Lyophilized Bacterial Lysates 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Romania | Om Pharma S.A. | Broncho-Vaxom Copii | Lyophilized Bacterial Lysates 3.5 mg Sachet | Powder For Oral Suspension | Oral Use |
| Romania | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units / Ml, Ribosomes Of Haemophilus Influenzae 0.5 Units / Ml, Ribosomes Of Streptococcus Pneumoniae 3 Units / Ml, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units / Ml, Ribosomes From Streptococcus Pyogenes Group A 3 Units / Ml | Granules For Oral Solution | Oral Use |
| Romania | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet | Tablet | Oral Use |
| Romania | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units | Granules For Oral Solution | Oral Use |
| Slovakia | Daiichi Sankyo Europe Gmbh | Luivac | Lysatum Bacteriale Mixtum 3 mg Tablet | Tablet | Oral Use |
| Slovakia | Om Pharma S.A. | Broncho-Vaxom | Lysatum Bacteriale Mixtum 7 mg Capsule | Capsule, Hard | Oral Use |
| Slovakia | Om Pharma S.A. | Broncho-Vaxom Pre Deti | Lysatum Bacteriale Mixtum 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Slovakia | Om Pharma S.A. | Broncho-Vaxom Pre Deti | Lysatum Bacteriale Mixtum 3.5 mg Sachet | Oral Powder | Oral Use |
| Slovakia | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Sachet, Ribosomes Of Haemophilus Influenzae 0.5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 3 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Sachet | Granules For Oral Solution | Oral Use |
| Slovakia | Pierre Fabre Medicament | Ribomunyl | Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet | Tablet | Oral Use |
| Slovenia | Lek Pharmaceuticals D.D. Ljubljana | Broncho-Munal | Bacterial Lysate 3.5 mg Capsule | Capsule, Hard | Oral Use |
| Slovenia | Lek Pharmaceuticals D.D. Ljubljana | Broncho-Munal | Bacterial Lysate 7 mg Capsule | Capsule, Hard | Oral Use |

Member State EU/EEA

Marketing authorisation holder

Invented name

INN + Strength

Pharmaceutical form

Route of administration

Austria

Daiichi Sankyo Austria Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Austria

Laboratorio Farmaceutico S.I.T. S.R.L.

Buccalin

Streptococcus Agalactiae 1 Giga Units Tablet, Haemophilus Influenzae 1.5 Giga Units Tablet, Staphylococcus Aureus 1 Giga Units Tablet, Streptococcus Pneumoniae 1 Giga Units Tablet

Film-Coated Tablet

Oral Use

Austria

Om Pharma S.A.

Broncho-Vaxom Für Erwachsene

Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7 mg Capsule

Capsule, Hard

Oral Use

Austria

Om Pharma S.A.

Broncho-Vaxom Für Kinder

Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5 mg Capsule

Capsule, Hard

Oral Use

Belgium

Om Pharma S.A.

Broncho Vaxom

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Belgium

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Bulgaria

Bb - Ncipd Ltd.

Respivax

Haemophilus Influenzae Type B (Hib) 0.625 Giga Cells / 25 mg, Branhamella Catarrhalis Lysate 0.625 Giga Cells / 25 mg, Klebsiella Pneumoniae (Inactivated) 0.625 Giga Cells / 25 mg, Staphylococcus Aureus Inactivated Bacteria 0.625 Giga Cells / 25 mg, Streptococcus Pneumoniae Inactivated Bacteria 0.625 Giga Cells / 25 mg, Streptococcus Pyogenes Inactivated Bacteria 0.625 Giga Cells / 25 mg

Tablet

Oral Use

Bulgaria

Bb - Ncipd Ltd.

Respivax

Haemophilus Influenzae Type B (Hib) 1.25 Giga Cells / 50 mg, Branhamella Catarrhalis Lysate 1.25 Giga Cells / 50 mg, Klebsiella Pneumoniae (Inactivated) 1.25 Giga Cells / 50 mg, Staphylococcus Aureus Inactivated Bacteria 1.25 Giga Cells / 50 mg, Streptococcus Pneumoniae Inactivated Bacteria 1.25 Giga Cells / 50 mg, Streptococcus Pyogenes Inactivated Bacteria 1.25 Giga Cells / 50 mg

Tablet

Oral Use

Bulgaria

Om Pharma S.A.

Бронхо – Ваксом За Възрастни

Standardized Lyophylisate Of Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Bulgaria

Om Pharma S.A.

Бронхо – Ваксом За Деца

Lyophilized Bacterial Lysates 3.5 mg Sachet

Granules

Oral Use

Bulgaria

Om Pharma S.A.

Бронхо–ваксом За Деца

Standardized Lyophylisate Of Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Bulgaria

Pierre Fabre Medicament

Рибомунил

Proteoglycanes Of Klebsiella Pneumoniae 1.125 mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70 % Rna) 0.75 mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet

Granules For Oral Solution

Oral Use

Czech Republic

Daiichi Sankyo Europe Gmbh

Luivac

Lysatum Bacteriale Mixtum 3 mg Tablet

Tablet

Oral Use

Czech Republic

Om Pharma S.A.

Broncho-Vaxom Pro Adultis

Lysatum Bacteriale Mixtum 7 mg Capsule

Capsule, Hard

Oral Use

Czech Republic

Om Pharma S.A.

Broncho-Vaxom Pro Infantibus

Lysatum Bacteriale Mixtum 3.5 mg Capsule

Capsule, Hard

Oral Use

Czech Republic

Om Pharma S.A.

Broncho-Vaxom Pro Infantibus

Lysatum Bacteriale Mixtum 3.5 mg Sachet

Granules In Sachet

Oral Use

Czech Republic

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Sachet, Ribosomes Of Haemophilus Influenzae 0.5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 3 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Sachet

Granules For Oral Solution

Oral Use

Czech Republic

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet

Tablet

Oral Use

Germany

Daiichi Sankyo Europe Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Germany

Om Pharma S.A.

Broncho-Munal Erwachsene

Lyophilised, Standardised Bacterial Extract 7 mg Capsule

Capsule, Hard

Oral Use

Germany

Om Pharma S.A.

Broncho-Munal Kinder

Lyophilised, Standardised Bacterial Extract 3.5 mg Capsule

Capsule, Hard

Oral Use

Germany

Om Pharma S.A.

Broncho-Vaxom

Lyophilised, Standardised Bacterial Extract 3.5 mg Capsule

Capsule, Hard

Oral Use

Germany

Om Pharma S.A.

Broncho-Vaxom Erwachsene

Lyophilised, Standardised Bacterial Extract 7 mg Capsule

Capsule

Oral Use

Greece

Gap S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Greece

Gap S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Greece

Rafarm Sa.

Pir-05

Lyophilized Bacterial Lysates 7 mg Tablet

Sublingual Tablet

Sublingual Use

Hungary

Om Pharma S.A.

Broncho-Vaxom Felnotteknek

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Hungary

Om Pharma S.A.

Broncho-Vaxom Gyermekeknek

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Hungary

Om Pharma S.A.

Broncho-Vaxom Gyermekeknek

Lyophilized Bacterial Lysates 3.5 mg Sachet

Powder For Oral Solution

Oral Use

Italy

Abiogen Pharma S.P.A.

Broncho Munal

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Italy

Abiogen Pharma S.P.A.

Broncho Munal

Lyophilized Bacterial Lysates 3.5 mg Sachet

Granules In Sachet

Oral Use

Italy

Abiogen Pharma S.P.A.

Broncho Munal

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Italy

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.

Ommunal

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Italy

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.

Ommunal

Lyophilized Bacterial Lysates 3.5 mg Sachet

Granules For Oral Suspension

Oral Use

Italy

Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.

Ommunal

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Italy

Bruschettini S.R.L

Immubron

Glycine 43 mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Oralis 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50 mg Tablet

Sublingual Tablet

Sublingual Use

Italy

Bruschettini S.R.L

Lantigen B

Haemophilus Influenzae Type B (Hib) 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2dagu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml

Oral Drops, Suspension

Oral Use

Italy

Daiichi Sankyo Italia S.P.A

Paspat

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Italy

Laboratorio Farmaceutico S.I.T. S.R.L.

Buccalin

Streptococcus Agalactiae 1 000 Mega Units Tablet, Haemophilus Influenzae 1 500 Mega Units Tablet, Staphylococcus Aureus 1 000 Mega Units Tablet, Streptococcus Pneumoniae 1 000 Mega Units Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Laboratorio Farmaceutico S.I.T. S.R.L.

Buccalin

Streptococcus Agalactiae 1 000 Mega Units Tablet, Haemophilus Influenzae 1 500 Mega Units Tablet, Staphylococcus Aureus 1 000 Mega Units Tablet, Streptococcus Pneumoniae 1 000 Mega Units Tablet

Gastro-Resistant Tablet

Oral Use

Italy

Lallemand Pharma Europe

Ismigen

Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 GigaCells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Oralis 6 GigaCells Tablet

Sublingual Tablet

Sublingual Use

Italy

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Italy

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Sachet

Granules In Sachet

Oral Use

Italy

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Italy

Pierre Fabre Pharma S.R.L.

Immucytal

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Granules For Oral Solution

Oral Use

Italy

Pierre Fabre Pharma S.R.L.

Immucytal

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Tablet

Oral Use

Latvia

Daiichi Sankyo Europe Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Latvia

Lek Pharmaceuticals D.D. Ljubljana

Broncho-Munal

Bacterial Lysate 3.5 mg Capsule

Capsule, Hard

Oral Use

Latvia

Lek Pharmaceuticals D.D. Ljubljana

Broncho-Munal

Bacterial Lysate 7 mg Capsule

Capsule, Hard

Oral Use

Lithuania

Daiichi Sankyo Europe Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Lithuania

Lek Pharmaceuticals D.D. Ljubljana

Broncho-Munal

Bacterial Lysate 7 mg Capsule

Capsule, Hard

Oral Use

Lithuania

Lek Pharmaceuticals D.D. Ljubljana

Broncho-Munal

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Lithuania

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Granules For Oral Solution

Oral Use

Lithuania

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Tablet

Oral Use

Luxembourg

Daiichi Sankyo Europe Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Luxembourg

Om Pharma S.A.

Broncho Vaxom

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Luxembourg

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Malta

Bruschettini S.R.L

Immubron

Glycine 43 mg Tablet, Haemophilus Influenzae Type B (Hib) 6 Giga Organisms Tablet, Klebsiella Ozaenae 6 Giga Organisms Tablet, Klebsiella Pneumoniae 6 Giga Organisms Tablet, Neisseria Catarrhalis 6 Giga Organisms Tablet, Staphylococcus Aureus 6 Giga Organisms Tablet, Streptococcus Pneumoniae 6 Giga Organisms Tablet, Streptococcus Pyogenes 6 Giga Organisms Tablet, Streptococcus Viridans 6 Giga Organisms Tablet, Lyophilized Bacterial Lysates 50 mg Tablet

Sublingual Tablet

Sublingual Use

Malta

Bruschettini S.R.L

Lantigen B

Haemophilus Influenzae Type B (Hib) 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2 agu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml

Oral Drops, Suspension

Oral Use

Poland

Daiichi Sankyo Europe Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Poland

Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna

Polyvaccinum Forte

Escherichia Coli (Inactivated) 200 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 100 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 500 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 500 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 100 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 100 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 100 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 200 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 100 Mega Cells / Ml

Suspension For Injection

Intramuscular Use $ Subcutaneous Use

Poland

Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna

Polyvaccinum Mite

Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml

Nasal Drops, Suspension

Nasal Use

Poland

Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna

Polyvaccinum Mite

Escherichia Coli (Inactivated) 20 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 10 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 50 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 50 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 10 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 10 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 10 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 20 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 10 Mega Cells / Ml

Suspension For Injection

Intramuscular Use $ Subcutaneous Use

Poland

Instytut Biotechnologii Surowic I Szczepionek Biomed Spółka Akcyjna

Polyvaccinum Submite

Escherichia Coli (Inactivated) 2 Mega Cells / Ml, Klebsiella Pneumoniae (Inactivated) 1 Mega Cells / Ml, Staphylococcus Aureus Inactivated Bacteria 5 Mega Cells / Ml, Staphylococcus Epidermidis Inactivated Bacteria 5 Mega Cells / Ml, Streptococcus Salivarius Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pneumoniae Inactivated Bacteria 1 Mega Cells / Ml, Streptococcus Pyogenes Inactivated Bacteria 1 Mega Cells / Ml, Haemophilus Influenzae Inactivated Bacteria 1 Mega Cells / Ml, Corynebacterium Pseudodiphtheriticum Inactivated Bacteria 2 Mega Cells / Ml, Moraxella Catarrhalis Inactivated Bacteria 1 Mega Cells / Ml

Suspension For Injection

Intramuscular Use $ Subcutaneous Use

Poland

Lallemand Pharma Europe

Ismigen

Haemophilus Influenzae 6 Giga Cells Tablet, Klebsiella Ozaenae 6 Giga Cells Tablet, Klebsiella Pneumoniae 6 Giga Cells Tablet, Neisseria Catarrhalis 6 Giga Cells Tablet, Staphylococcus Aureus 6 Giga Cells Tablet, Streptococcus Pneumoniae 6 Giga Cells Tablet, Streptococcus Pyogenes 6 Giga Cells Tablet, Streptococcus Viridans 6 Giga Cells Tablet

Sublingual Tablet

Sublingual Use

Poland

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Poland

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Sachet

Granules In Sachet

Oral Use

Poland

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Poland

Pierre Fabre Medicament Polska Sp. Z O.O.

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet

Tablet

Oral Use

Poland

Pierre Fabre Medicament Polska Sp. Z O.O.

Ribomunyl

Proteoglycanes Of Klebsiella Pneumoniae 1.125 mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70 % Rna) 0.75 mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet

Granules For Oral Solution

Oral Use

Poland

Pierre Fabre Medicament Polska Sp. Z O.O.

Ribomunyl

Proteoglycanes Of Klebsiella Pneumoniae 1.125 mg Sachet, Ribosomes Of Haemophilus Influenzae 5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 30 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 35 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 30 Units Sachet

Granules For Oral Solution

Oral Use

Portugal

Almirall Produtos Farmacêuticos, Lda.

Provax

Diplococcus Pneumoniae Type I 6 000 Milli I.U. Tablet, Haemophilus Influenzae 6 000  Milli I.U. Tablet, Klebsiella Ozaenae 6 Milli I.U. Tablet, Klebsiella Pneumoniae 6 000  Milli I.U. Tablet, Neisseria Catarrhalis 6 000 Milli I.U. Tablet, Staphylococcus Aureus 6 000 Milli I.U. Tablet, Streptococcus Pyogenes 6 000 Milli I.U. Tablet, Streptococcus Viridans 6 000  Milli I.U. Tablet

Tablet

Oral Use

Portugal

Daiichi Sankyo Portugal, Unip. Lda

Paspat Oral

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Portugal

Lusomedicamenta – Sociedade Técnica Farmacêutica, Sa

Lantigen B

Haemophilus Influenzae 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2 agu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml

Oral Suspension

Sublingual Use

Portugal

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 3.5 mg Sachet

Granules

Oral Use

Portugal

Om Pharma S.A.

Broncho-Vaxom

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Portugal

Om Pharma S.A.

Broncho-Vaxom Infantil,

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Portugal

Pierre Fabre Médicament Portugal, Lda.

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet

Tablet

Oral Use

Portugal

Pierre Fabre Médicament Portugal, Lda.

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Granules For Oral Solution

Oral Use

Portugal

Pierre Fabre Médicament Portugal, Lda.

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Tablet

Oral Use

Romania

Alvogen Malta Operations (Row) Ltd

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Romania

Bruschettini S.R.L

Lantigen B

Haemophilus Influenzae Type B (Hib) 50.2 agu/Ml, Klebsiella Pneumoniae 39.8 agu/Ml, Staphylococcus Aureus 79.6 agu/Ml, Streptococcus Pneumoniae 63.2 agu/Ml, Streptococcus Pyogenes 126.2 agu/Ml, Moraxella Catarrhalis 39.9 agu/Ml

Oral Drops, Suspension

Oral Use

Romania

Daiichi Sankyo Europe Gmbh

Luivac

Bacterial Lysate 3 mg Tablet

Tablet

Oral Use

Romania

Om Pharma S.A.

Broncho-Vaxom Adulți

Lyophilized Bacterial Lysates 7 mg Capsule

Capsule, Hard

Oral Use

Romania

Om Pharma S.A.

Broncho-Vaxom Copii

Lyophilized Bacterial Lysates 3.5 mg Capsule

Capsule, Hard

Oral Use

Romania

Om Pharma S.A.

Broncho-Vaxom Copii

Lyophilized Bacterial Lysates 3.5 mg Sachet

Powder For Oral Suspension

Oral Use

Romania

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units / Ml, Ribosomes Of Haemophilus Influenzae 0.5 Units / Ml, Ribosomes Of Streptococcus Pneumoniae 3 Units / Ml, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units / Ml, Ribosomes From Streptococcus Pyogenes Group A 3 Units / Ml

Granules For Oral Solution

Oral Use

Romania

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units Tablet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet

Tablet

Oral Use

Romania

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units, Ribosomes Of Haemophilus Influenzae 0.5 Units, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units, Ribosomes From Streptococcus Pyogenes Group A 3 Units

Granules For Oral Solution

Oral Use

Slovakia

Daiichi Sankyo Europe Gmbh

Luivac

Lysatum Bacteriale Mixtum 3 mg Tablet

Tablet

Oral Use

Slovakia

Om Pharma S.A.

Broncho-Vaxom

Lysatum Bacteriale Mixtum 7 mg Capsule

Capsule, Hard

Oral Use

Slovakia

Om Pharma S.A.

Broncho-Vaxom Pre Deti

Lysatum Bacteriale Mixtum 3.5 mg Capsule

Capsule, Hard

Oral Use

Slovakia

Om Pharma S.A.

Broncho-Vaxom Pre Deti

Lysatum Bacteriale Mixtum 3.5 mg Sachet

Oral Powder

Oral Use

Slovakia

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Sachet, Ribosomes Of Haemophilus Influenzae 0.5 Units Sachet, Ribosomes Of Streptococcus Pneumoniae 3 Units Sachet, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Sachet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Sachet

Granules For Oral Solution

Oral Use

Slovakia

Pierre Fabre Medicament

Ribomunyl

Membranes Fractions Of Klebsiella Pneumoniae 15 Units Tablet, Ribosomes Of Haemophilus Influenzae 0.5 Units Tablet, Ribosomes Of Streptococcus Pneumoniae 3 Units, Ribosomal Fractions Of Klebsiella Pneumoniae 3.5 Units Tablet, Ribosomes From Streptococcus Pyogenes Group A 3 Units Tablet

Tablet

Oral Use

Slovenia

Lek Pharmaceuticals D.D. Ljubljana

Broncho-Munal

Bacterial Lysate 3.5 mg Capsule

Capsule, Hard

Oral Use

Slovenia

Lek Pharmaceuticals D.D. Ljubljana

Broncho-Munal

Bacterial Lysate 7 mg Capsule

Capsule, Hard

Oral Use

---

ANNEX II

List of the names, pharmaceutical form, strengths of the veterinary medicinal products, animal species, route of administration, applicants and marketing authorisation holders in the Member States

| Member State EU/EEA | Applicant / Marketing authorisation holder | Name | INN | Strength | Pharmaceutical form | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Biovet JSC |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Member State EU/EEA

Applicant / Marketing authorisation holder

Name

INN

Strength

Pharmaceutical form

Animal species

Route of administration

Austria

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Axentyl 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Austria

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Austria

| Vana GmbH |
| --- |
| Wolfgang Schmälzl-Gasse 6 |
| 1020 Wien |
| Austria |

Vana GmbH

Wolfgang Schmälzl-Gasse 6

1020 Wien

Austria

Vanatyl 200 mg/ml - Injektionslösung für Tiere

Tylosin base

200 mg/ml

Solution for injection

Cattle, dogs, goats, pigs, sheep

Sheep: Intramuscular route

Austria

| CEVA Santé Animale |
| --- |
| 10 Avenue De La Ballastiere |
| 33500 Libourne |
| France |

CEVA Santé Animale

10 Avenue De La Ballastiere

33500 Libourne

France

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Bulgaria

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Bulgaria

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Pharmasin 50 solution for injection

Tylosin base

50 mg/ml

Solution for injection

Cats, cattle, dogs, goats, pigs, sheep

Sheep: Intramuscular route

Bulgaria

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylovet B-200 solution for injection for cattle, sheep, goats, swine and dogs

Tylosin base

200 mg/ml

Solution for injection

Cattle, dogs, goats, pigs, sheep

Sheep: Intramuscular route

Bulgaria

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylovet B-50, solution for injection for cattle, sheep, goats, swine, dogs and cats

Tylosin base

50 mg/ml

Solution for injection

Cats, cattle, dogs, goats, pigs, sheep

Sheep: Intramuscular route

Bulgaria

| CEVA Santé Animale |
| --- |
| 10 Avenue De La Ballastiere |
| 33500 Libourne |
| France |

CEVA Santé Animale

10 Avenue De La Ballastiere

33500 Libourne

France

Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goat

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Denmark

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Tylmasin

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Denmark

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylovet

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Denmark

| Ceva Animal Health A/S |
| --- |
| Ladegårdsvej 2 |
| DK-7100 Vejle |
| Denmark |

Ceva Animal Health A/S

Ladegårdsvej 2

DK-7100 Vejle

Denmark

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Estonia

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14

Püünsi, Viimsi vald

74013 Harju maakond

Estonia

Macrolan-200

Tylosin base

200 mg/ml

Solution for injection

Cattle, pigs, sheep

Sheep: Intramuscular route

Estonia

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

France

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

AXENTYL 200 MG/ML SOLUTION INJECTABLE POUR BOVINS, OVINS, CAPRINS ET PORCINS

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

France

Bimeda Animal Health

Unit 2/3/4 Airton Close

Tallaght

Dublin 24

Ireland

BILOVET 200 MG/ML SOLUTION INJECTABLE

Tylosin base

200 mg/ml

Solution for injection

Sheep

Sheep: Intramuscular route

France

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

France

| LILLY France |
| --- |
| 24 Boulevard Vital Bouhot |
| 92200 Neuilly Sur Seine |
| France |

LILLY France

24 Boulevard Vital Bouhot

92200 Neuilly Sur Seine

France

TYLAN 200

Tylosin base

200 mg/ml

Solution for injection

Sheep

Sheep: Intramuscular route

France

| CEVA Santé Animale |
| --- |
| 10 Avenue De La Ballastiere |
| 33500 Libourne |
| France |

CEVA Santé Animale

10 Avenue De La Ballastiere

33500 Libourne

France

TILJET 200 MG/ML SOLUTION INJECTABLE POUR BOVINS OVINS CAPRINS ET PORCINS

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Germany

| CEVA Santé Animale |
| --- |
| 10 Avenue De La Ballastiere |
| 33500 Libourne |
| France |

CEVA Santé Animale

10 Avenue De La Ballastiere

33500 Libourne

France

Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Germany

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Germany

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin 200 mg/ml Injektionslösung für Rinder, Schafe, Ziegen und Schweine

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Greece

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Greece

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylmasin

Tylosin tartrate

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Greece

| Ceva Hellas LLC |
| --- |
| 15 Agiou Nikolaou Street |
| 17455, Alimos |
| Greece |

Ceva Hellas LLC

15 Agiou Nikolaou Street

17455, Alimos

Greece

Tiljet

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Greece

| A. Nikolakopoulos S.A. |
| --- |
| 115 Galatsi Avenue |
| 11146, Galatsi |
| Greece |

A. Nikolakopoulos S.A.

115 Galatsi Avenue

11146, Galatsi

Greece

Tilocen

Tylosin tartrate

200 mg/ml

Solution for injection

Cattle, sheep, pigs, dogs, cats

Sheep: Intramuscular route

Greece

Anafasis LTD

Santorinis 3

Pallouriotissa

1048 Nicosia

Cyprus

Tylosin/Anafasis

Tylosin tartrate

200 mg/ml

Solution for injection

Cattle, sheep, pigs, dogs, cats

Sheep: Intramuscular route

Hungary

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Hungary

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TYLMASIN 200 mg/ml oldatos injekció szarvasmarhák, juhok, kecskék és sertések részére

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Ireland

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Ireland

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylosin Biovet JSC 200 mg/ml solution for injection for cattle, sheep, goats and pigs

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Ireland

| CEVA Santé Animale |
| --- |
| 10 Avenue De La Ballastiere |
| 33500 Libourne |
| France |

CEVA Santé Animale

10 Avenue De La Ballastiere

33500 Libourne

France

Tiljet Solution for Injection

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Italy

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

AXENTYL 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Italy

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Latvia

Interchemie Werken De Adelaar Eesti AS

Vanapere tee 14

Püünsi, Viimsi vald

74013 Harju maakond

Estonia

LV Macrolan

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route.

Latvia

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Lithuania

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 50 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims, ožkoms, šunims ir katėms

Tylosin base

50 mg/ml

Solution for injection

Cats, cattle, dogs, goats, pigs, sheep

Sheep: Intramuscular route

Lithuania

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml injekcinis tirpalas kiaulėms, galvijams, avims ir ožkoms

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Poland

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylozyna Biovet JSC

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Poland

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Poland

| Ceva Animal Health Polska Sp.zo.o. |
| --- |
| Ul. Okrzei 1a |
| Warszawa 03-715 |
| Poland |

Ceva Animal Health Polska Sp.zo.o.

Ul. Okrzei 1a

Warszawa 03-715

Poland

Tiljet 200 mg/ml solution for injection for cattle, pigs, sheep and goats

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Portugal

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

AXENTYL 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Portugal

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml soluzione iniettabile per bovini, ovini, caprini e suini

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Romania

S.C. Pasteur - Filiala Filipesti

Str. Principala, nr. 944

Filipestii de Padure

Jud. Prahova

Romania

Tilozina FP

Tylosin tartrate

200 mg/ml

Solution for injection

Sheep

Sheep: Intramuscular route

Romania

Romvac Company SA

Sos. Centurii nr.7

07718, Voluntari

Jud. Ilfov

Romania

Tylavet

Tylosin tartrate

200 mg/ml

Solution for injection

Sheep

Sheep: Intramuscular route

Romania

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

Pharmasin 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Romania

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

Tylmasin 200 mg/ml

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Spain

| Huvepharma NV |
| --- |
| Uitbreidingstraat 80 |
| 2600 Antwerpen |
| Belgium |

Huvepharma NV

Uitbreidingstraat 80

2600 Antwerpen

Belgium

PHARMASIN 200 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO CAPRINO Y PORCINO

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Spain

| Biovet JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Peshtera |
| Bulgaria |

Biovet JSC

39 Petar Rakov Str.

4550 Peshtera

Bulgaria

TILOSINA BIOVET JSC 200 mg/ml SOLUCION INYECTABLE PARA BOVINO OVINO CAPRINO Y PORCINO

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

Spain

| CEVA SALUD ANIMAL, S.A. |
| --- |
| Avda. Diagonal, 609-615 |
| 08028 Barcelona |
| Spain |

CEVA SALUD ANIMAL, S.A.

Avda. Diagonal, 609-615

08028 Barcelona

Spain

TILJET 200 mg/ml SOLUCION INYECTABLE PARA BOVINO, OVINO, CAPRINO Y PORCINO

Tylosin base

200 mg/ml

Solution for injection

Cattle, goats, pigs, sheep

Sheep: Intramuscular route

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