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)
Date: 2019-10-30
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product








C_2019369EN.01001101.xml










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















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










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






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






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






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






Tiljet


Tylosin base


200 mg/ml


Solution for injection


Cattle, goats, pigs, sheep


Sheep: Intramuscular route




Bulgaria







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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






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






Pharmasin


Tylosin base


200 mg/ml


Solution for injection


Cattle, goats, pigs, sheep


Sheep: Intramuscular route




Lithuania







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






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






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






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






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






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






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






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






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






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






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






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