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Document 52019XC1030(03)

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)

OJ C 369, 30.10.2019, p. 11–29 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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


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