natgillin/translations-raw huggingface dataset:
Powder: vial (glass) Solvent: pre-filled syringe (glass) 
Pulber: Viaalis (klaas) Lahusti: täidepud süstel (klaas)
EU/1/06/335/001 Valtropin 15 mg/1.5 ml Powder and solvent for solution for injection (multi-use) 
EU/1/06/335/001 Valtropin
Content (concentration) 
Manustamistee Pakendi iseloomustus Pakendi sisu (kontsentratsioon)
Tablet 
tablett
Gastro-Resistant Tablet 
Gastroresistentne tablett
Intramuscular Use $ 
Süstesuspensioon Intramuskulaarne $ subkutaanne
Czech Republic Om Pharma S.A. 
Tšehhi Vabariik Om Pharma S.A.
Nasal Drops, Suspension 
Ninatilgad, suspensioon
Annex I List of nationally authorised medicinal products 
Lisa I Riikliku müügiloaga ravimpreparaatide loend
Luxembourg Om Pharma S.A. 
Luksemburg Om Pharma S.A.
Czech Republic Pierre Fabre Medicament Ribomunyl 
Tšehhi Vabariik Pierre Fabre Medicament Ribomunyl
Tablet, Klebsiella Ozaenae 6 Milli I.U. 
tablett, Klebsiella Ozaenae 6 Milli I.U.
Diplococcus Pneumoniae Type I 6000 Milli I.U. 
Diplococcus Pneumoniae tüüp I 6000 Milli I.U.
Tablet, Haemophilus Influenzae 6000 Milli I.U. 
tablett, Haemophilus Influenzae 6000 Milli I.U.
Tablet, Neisseria Catarrhalis 6000 Milli I.U. 
tablett, Neisseria Catarrhalis 6000 Milli I.U.
Tablet, Klebsiella Pneumoniae 6000 Milli I.U. 
tablett, Klebsiella Pneumoniae 6000 Milli I.U.
Tablet, Staphylococcus Aureus 6000 Milli I.U. 
tablett, Staphylococcus Aureus 6000 Milli I.U.
Streptococcus Agalactiae 1000 Mega Units Tablet, Haemophilus Influenzae 1500 Mega Units Tablet, Staphylococcus Aureus 1000 Mega Units Tablet, Streptococcus Pneumoniae 1000 Mega Units Tablet 
Streptococcus Agalactiae 1000 Mega ühikut tablett, Haemophilus Influenzae 1500 Mega ühikut tablett, Staphylococcus Aureus 1000 Mega ühikut tablett, Streptococcus Pneumoniae 1000 Mega ühikut tablett
Lysatum Bacteriale Mixtum 3mg Tablet 
Lysatum Bacteriale Mixtum 3 mg tablett
Haemophilus Influenzae Type B (Hib) 1.25 Giga Cells / 50mg, Branhamella Catarrhalis Lysate 1.25 Giga Cells / 50mg, Klebsiella Pneumoniae (Inactivated) 1.25 Giga Cells / 50mg, Staphylococcus Aureus Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pneumoniae Inactivated Bacteria 1.25 Giga Cells / 50mg, Streptococcus Pyogenes Inactivated Bacteria 1.25 Giga Cells / 50mg 
Haemophilus Influenzae Type B (Hib) 1,25 Giga rakku / 50 mg, Branhamella Catarrhalis lüsaat 1,25 Giga rakku / 50 mg, Klebsiella Pneumoniae (inaktiveeritud) 1,25 Giga rakku / 50 mg, Staphylococcus Aureus inaktiveeritud bakterid 1,25 Giga rakku / 50 mg, Streptococcus Pneumoniae inaktiveeritud bakterid 1,25 Giga rakku / 50 mg, Streptococcus Pyogenes inaktiveeritud bakterid 1,25 Giga rakku / 50 mg
Haemophilus Influenzae Type B (Hib) 0.625 Giga Cells / 25mg, Branhamella Catarrhalis Lysate 0.625 Giga Cells / 25mg, Klebsiella Pneumoniae (Inactivated) 0.625 Giga Cells / 25mg, Staphylococcus Aureus Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pneumoniae Inactivated Bacteria 0.625 Giga Cells / 25mg, Streptococcus Pyogenes Inactivated Bacteria 0.625 Giga Cells / 25mg 
Haemophilus Influenzae Type B (Hib) 0,625 Giga rakku / 25 mg, Branhamella Catarrhalis lüsaat 0,625 Giga rakku / 25 mg, Klebsiella Pneumoniae (inaktiveeritud) 0,625 Giga rakku / 25 mg, Staphylococcus Aureus inaktiveeritud bakterid 0,625 Giga rakku / 25 mg, Streptococcus Pneumoniae inaktiveeritud bakterid 0,625 Giga rakku / 25 mg, Streptococcus Pyogenes inaktiveeritud bakterid 0,625 Giga rakku / 25 mg
Tablet, Streptococcus Viridans 6000 Milli I.U. 
tablett, Streptococcus Viridans 6000 Milli I.U.
Tablet, Streptococcus Pyogenes 6000 Milli I.U. 
tablett, Streptococcus Pyogenes 6000 Milli I.U.
Bacterial Lysate 3mg Tablet 
Bakteriaalne lüsaat 3 mg tablett
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 
Streptococcus Agalactiae 1 Giga ühik tablett, Haemophilus Influenzae 1,5 Giga ühikut tablett, Staphylococcus Aureus 1 Giga ühik tablett, Streptococcus Pneumoniae 1 Giga ühik tablett
Granules For Oral Suspension 
Suukaudse suspensiooni graanulid
Lysatum Bacteriale Mixtum 3.5mg Capsule 
Lysatum Bacteriale Mixtum 3,5 mg kapsel
Lysatum Bacteriale Mixtum 7mg Capsule 
Lysatum Bacteriale Mixtum 7 mg kapsel
Lyophilised, Standardised Bacterial Extract 7mg Capsule 
Lüofiliseeritud, standardiseeritud bakteriaalne ekstrakt 7 mg kapsel
Haemophilus Influenzae Type B (Hib) 50.2agu/Ml, Klebsiella Pneumoniae 39.8agu/Ml, Staphylococcus Aureus 79.6agu/Ml, Streptococcus Pneumoniae 63.2agu/Ml, Streptococcus Pyogenes 126.2agu/Ml, Moraxella Catarrhalis 39.9agu/Ml 
Haemophilus Influenzae tüüp 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
Broncho-Vaxom Lysatum Bacteriale Mixtum 7mg Capsule 
Broncho-Vaxom Lysatum Bacteriale Mixtum 7 mg kapsel
Czech Republic Daiichi Sankyo Europe Gmbh 
Tšehhi Vabariik Daiichi Sankyo Europe Gmbh
Bacterial Lysate 7mg Capsule 
Bakteriaalne lüsaat 7 mg kapsel
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 
Escherichia Coli (inaktiveeritud) 2 Mega rakku / Ml, Klebsiella Pneumoniae (inaktiveeritud) 1 Mega rakku / Ml, Staphylococcus Aureus inaktiveeritud bakterid 5 Mega rakku / Ml, Staphylococcus Epidermidis inaktiveeritud bakterid 5 Mega rakku / Ml, Streptococcus Salivarius inaktiveeritud bakterid 1 Mega rakku / Ml, Streptococcus Pneumoniae inaktiveeritud bakterid 1 Mega rakku / Ml, Streptococcus Pyogenes inaktiveeritud bakterid 1 Mega rakku / Ml, Haemophilus Influenzae inaktiveeritud bakterid 1 Mega rakku / Ml, Corynebacterium Pseudodiphtheriticum inaktiveeritud bakterid 2 Mega rakku / Ml, Moraxella Catarrhalis inaktiveeritud bakterid 1 Mega rakku / Ml
Broncho-Vaxom Lyophilised, Standardised Bacterial Extract 3.5mg Capsule 
Broncho-Vaxom Lüofiliseeritud, standardiseeritud bakteriaalne ekstrakt 3,5 mg kapsel
Lyophilised, Standardised Bacterial Extract 3.5mg Capsule 
Lüofiliseeritud, standardiseeritud bakteriaalne ekstrakt 3,5 mg kapsel
Suspension For Injection 
Suukaudse suspensiooni pulber
Lyophilized Bacterial Lysates 7mg Tablet 
Lüofiliseeritud bakteriaalsed lüsaadid 7 mg tablett Keelealune tablett
Bacterial Lysate 3.5mg Capsule 
Bakteriaalne lüsaat 3,5 mg kapsel
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 
Mega rakku / Ml, Staphylococcus Aureus inaktiveeritud bakterid 50 Mega rakku / Ml, Staphylococcus Epidermidis inaktiveeritud bakterid 50 Mega rakku / Ml, Streptococcus Salivarius inaktiveeritud bakterid 10 Mega rakku / Ml, Streptococcus Pneumoniae inaktiveeritud bakterid 10 Mega rakku / Ml, Streptococcus Pyogenes inaktiveeritud bakterid 10 Mega rakku / Ml, Haemophilus Influenzae inaktiveeritud bakterid 10 Mega rakku / Ml, Corynebacterium Pseudodiphtheriticum inaktiveeritud bakterid 20 Mega rakku / Ml, Moraxella Catarrhalis inaktiveeritud bakterid 10 Mega rakku / Ml
Oral Powder 
Suukaudne pulber
Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule 
Broncho-Vaxom Lüofiliseeritud bakteriaalsed lüsaadid 3,5 mg kapsel
Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7mg Capsule 
Külmutuskuivatatud (lüofiliseeritud), standardiseeritud bakteriaalne lüsaat 7 mg kapsel
Proteoglycanes Of Klebsiella Pneumoniae 1.125mg Sachet, Ribosomal Fractions (Ribosomes With A Titre Of 70% Rna) 0.75mg 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 
Klebsiella Pneumoniae proteoglükaanid 1 125 mg kotike, ribosoomiosakesed (ribosoomid 70 % RNA tiitriga) 0,75 mg kotike, Haemophilus Influenzae ribosoomid 5 ühikut kotike, Streptococcus Pneumoniae ribosoomid 30 ühikut kotike, Klebsiella Pneumoniae ribosoomiosakesed 35 ühikut kotike, Streptococcus Pyogenes grupi A ribosoomid 30 ühikut kotike
Luxembourg Daiichi Sankyo Europe Gmbh 
Luksemburg Daiichi Sankyo Europe Gmbh
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 
Mega rakku / Ml, Staphylococcus Aureus inaktiveeritud bakterid 500 Mega rakku / Ml, Staphylococcus Epidermidis inaktiveeritud bakterid 500 Mega rakku / Ml, Streptococcus Salivarius inaktiveeritud bakterid 100 Mega rakku / Ml, Streptococcus Pneumoniae inaktiveeritud bakterid 100 Mega rakku / Ml, Streptococcus Pyogenes inaktiveeritud bakterid 100 Mega rakku / Ml, Haemophilus Influenzae inaktiveeritud bakterid 100 Mega rakku / Ml, Corynebacterium Pseudodiphtheriticum inaktiveeritud bakterid 200 Mega rakku / Ml, Moraxella Catarrhalis inaktiveeritud bakterid 100 Mega rakku / Ml
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 
Klebsiella Pneumoniae membraaniosakesed 15 ühikut / Ml, Haemophilus Influenzae ribosoomid 0,5 ühikut / Ml, Streptococcus Pneumoniae ribosoomid 3 ühikut / Ml, Klebsiella Pneumoniae ribosoomiosakesed 3,5 ühikut / Ml, Streptococcus Pyogenes grupi A ribosoomid 3 ühikut / Ml
Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule 
Külmkuivatatud (lüofiliseeritud), standardiseeritud bakteriaalne lüsaat 3,5 mg kapsel
Glycine 43mg 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 50mg Tablet 
Glütsiin 43 mg tablett, Haemophilus Influenzae tüüp B (Hib) 6 Giga organismi tablett, Klebsiella Ozaenae 6 Giga organismi tablett, Klebsiella Pneumoniae 6 Giga organismi tablett, Neisseria Catarrhalis 6 Giga organismi tablett, Staphylococcus Aureus 6 Giga organismi tablett, Streptococcus Pneumoniae 6 Giga organismi tablett, Streptococcus Pyogenes 6 Giga organismi tablett, Streptococcus Oralis 6 Giga organismi tablett, lüofiliseeritud bakteriaalsed lüsaadid 50mg tablett
Glycine 43mg 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 50mg Tablet 
Glütsiin 43 mg tablett, Haemophilus Influenzae tüüp B (Hib) 6 Giga organismi tablett, Klebsiella Ozaenae 6 Giga organismi tablett, Klebsiella Pneumoniae 6 Giga organismi tablett, Neisseria Catarrhalis 6 Giga organismi tablett, Staphylococcus Aureus 6 Giga organismi tablett, Streptococcus Pneumoniae 6 Giga organismi tablett, Streptococcus Pyogenes 6 Giga organismi tablett, Streptococcus Viridans 6 Giga organismi tablett, lüofiliseeritud bakteriaalsed lüsaadid 50 mg tablett
Proteoglycanes Of Klebsiella Pneumoniae 1.125mg 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 
Klebsiella Pneumoniae proteoglükaanid 1 125 mg kotike, Haemophilus Influenzae ribosoomid 5 ühikut kotike, Streptococcus Pneumoniae ribosoomid 30 ühikut kotike, Klebsiella Pneumoniae ribosoomiosakesed 35 ühikut kotike, Streptococcus Pyogenes grupi A ribosoomid 30 ühikut kotike
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 6GigaCells Tablet 
Haemophilus Influenzae 6 Giga rakku tablett, Klebsiella Ozaenae 6 Giga rakku tablett, Klebsiella Pneumoniae 6 Giga rakku tablett, Neisseria Catarrhalis 6 Giga rakku tablett, Staphylococcus Aureus 6 Giga rakku tablett, Streptococcus Pneumoniae 6 Giga rakku tablett, Streptococcus Pyogenes 6 Giga rakku tablett, Streptococcus Oralis 6 Giga rakku tablett
Lyophilized Bacterial Lysates 7mg Capsule 
Lüofiliseeritud bakteriaalsed lüsaadid 7 mg kapsel
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 
Haemophilus Influenzae 6 Giga rakku tablett, Klebsiella Ozaenae 6 Giga rakku tablett, Klebsiella Pneumoniae 6 Giga rakku tablett, Neisseria Catarrhalis 6 Giga rakku tablett, Staphylococcus Aureus 6 Giga rakku tablett, Streptococcus Pneumoniae 6 Giga rakku tablett, Streptococcus Pyogenes 6 Giga rakku tablett, Streptococcus Viridans 6 Giga rakku tablett
Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet 
Broncho-Vaxom Lüofiliseeritud bakteriaalsed lüsaadid 3,5 mg kotike
Broncho-Vaxom Lyophilized Bacterial Lysates 7mg Capsule 
Broncho-Vaxom Lüofiliseeritud bakteriaalsed lüsaadid 7 mg kapsel
Broncho Vaxom Lyophilized Bacterial Lysates 7mg Capsule 
Broncho Vaxom Lüofiliseeritud bakteriaalsed lüsaadid 7 mg kapsel
Lysatum Bacteriale Mixtum 3.5mg Sachet 
Lysatum Bacteriale Mixtum 3,5 mg kotike
Lyophilized Bacterial Lysates 3.5mg Capsule 
Lüofiliseeritud bakteriaalsed lüsaadid 3,5 mg kapsel
Film-Coated Tablet 
Õhukese polümeerikattega tablett
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 
Klebsiella Pneumoniae membraaniosakesed 15 ühikut tablett, Haemophilus Influenzae ribosoomid 0,5 ühikut tablett, Streptococcus Pneumoniae ribosoomid 3 ühikut tablett, Klebsiella Pneumoniae ribosoomiosakesed 3,5 ühikut tablett, Streptococcus Pyogenes grupi A ribosoomid 3 ühikut tablett
Standardized Lyophylisate Of Bacterial Lysates 7mg Capsule 
Bakteriaalsete lüsaatide standardiseeritud lüofilisaat 7 mg kapsel
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 
Klebsiella Pneumoniae membraaniosakesed 15 ühikut, Haemophilus Influenzae ribosoomid 0,5 ühikut, Streptococcus Pneumoniae ribosoomid 3 ühikut, Klebsiella Pneumoniae ribosoomiosakesed 3,5 ühikut, Streptococcus Pyogenes grupi A ribosoomid 3 ühikut
Granules In Sachet 
Graanulid kotikeses
Standardized Lyophylisate Of Bacterial Lysates 3.5mg Capsule 
Bakteriaalsete lüsaatide standardiseeritud lüofilisaat 3,5 mg kapsel
3 inhalers (3 x 30 doses) (multipack) 
3 inhalaatorit (3x30 annust) (multipakend)
Strength Pharmaceutical Form Route of Administration 
Ravimvorm Manustamistee
Immediate Packaging 
Vahetu sisepakend Pakendi suurus
Pack size 
Liidus
18 June 2012 
18. juuni 2012
The final opinion was converted into a Decision by the European Commission on 18 June 2012. 
Lõplik arvamus kinnitati Euroopa Komisjoni otsusena 18. juunil 2012.
The referral procedure started on 14 September 2011. 
Esildise menetlemine algas 14. septembril 2011.
Written explanations were provided by the marketing authorisation holder on 2 December 2011. 
Müügiloa hoidja esitas kirjalikud selgitused 2. detsembril 2011.
Febantel is a probenzimidazole. 
Febanteel on probensimidasool.
These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes. 
Need veterinaarravimid on näidustatud nematoodidest ja tsestoodidest põhjustatud mitmesuguste parasiitinfektsioonide raviks koertel.
The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the amended summary of product characteristics, package leaflet and labelling in the Annex III. 
Asjaomased raviminimetused on I lisas, teaduslikud järeldused II lisas ning muudetud ravimi omaduste kokkuvõte, märgitus ja pakendi infoleht III lisas.
International non-proprietary name (inn): Praziquantel, pyrantel and febantel 
Rahvusvaheline mittekaubanduslik nimetus (INN): pratsikvanteel, püranteel ja febanteel
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus (and associated names) are veterinary medicinal products as tablets for dogs containing 50 mg praziquantel, 50 mg pyrantel (equivalent to 144 mg pyrantel embonate) and 150 mg of febantel. 
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus ja Prazitel Plus (ja seotud nimetused) on veterinaarravimid, tabletid koertele, mis sisaldavad 50 mg pratsikvanteeli, 50 mg püranteeli (ekvivalentne 144 mg embonaatpüranteeliga) ja 150 mg febanteeli.
Pyrantel embonate (pamoate) is a tetrahydropyrimidine derivative. 
Embonaatpüranteel (pamoaat) on tetrahüdropürimidiini derivatiiv.
Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative. 
Pratsikvanteel on püratsinoisokvinoliini osaliselt hüdrogeenitud derivaat.
Opinion following an Article 34 
kohasele esildisele järgnev arvamus
Due to the divergent national decisions taken by Member States regarding the indications and use in pups less than 9 weeks of age and dogs weighing less than 2.5 kg concerning the authorisations of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names, on 22 July 2011 France referred the issue to the CVMP under Article 34(1) of Directive 2001/82/EC, in order to resolve the above mentioned divergences. 
Et liikmesriigid olid ravimite Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus ja seotud nimetuste näidustuste ja kasutamise kohta alla 9-nädalastel kutsikatel ja alla 2,5 kg kaaluvatel koertel vastu võtnud erisuguseid otsuseid, tegi Prantsusmaa 22. juulil 2011 veterinaarravimite komiteele direktiivi 2001/82/EÜ artikli 34 lõike 1 kohase esildise, et eemaldada nimetatud erisused.
Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus and associated names (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) remains positive subject to variation of the marketing authorisations in accordance with the recommended changes to the product information. 
Tuginedes olemasolevate andmete hindamisele, otsustas veterinaarravimite komitee, et ravimite Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus ja seotud nimetuste (heaks kiidetud vastastikuse tunnustamise menetluse nr IE/V/0272-0275/001/MR alusel) kasulikkuse ja riski suhe on positiivne, kui müügilubadesse tehakse parandused vastavalt soovitatud muudatustele ravimiteabes.
Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names 
Ravimite Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus ja Prazitel Plus ja seotud nimetuste artikli 34
terms of the marketing authorisations for Milaxyn Plus, Strantel Plus, Prazical Plus and Voxical Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0272-0275/001/MR) and the maintenance of the marketing authorisations for Prazitel Plus, Exitel Plus and Cazitel Plus (and associated names) (authorised via Mutual Recognition Procedure No IE/V/0241-0243/001/MR). 
veterinaarkomitee 7. märtsil 2012 positiivse otsuse, soovitades muuta ravimite Milaxyn Plus, Strantel Plus, Prazical Plus ja Voxical Plus (ja seotud nimetuste) (heaks kiidetud vastastikuse tunnustamise menetluse nr IE/V/0272-0275/001/MR alusel) müügilubade tingimusi ja säilitada ravimite Prazitel Plus, Exitel Plus ja Cazitel Plus (ja seotud nimetuste) (heaks kiidetud vastastikuse tunnustamise menetluse nr IE/V/0241-0243/001/MR alusel) müügiload.
Opinion following an Article 34F F referral for Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus and Prazitel Plus and associated names EMA/289985/2012 
Ravimite Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus ja Prazitel Plus ja seotud nimetuste artikli 34F F kohasele esildisele järgnev arvamus EMA/480402/2012
educational and social measures. 
pedagoogilised ja sotsiaalseid meetmed.
• it is used in children and adolescents aged 6-17 years. 
• seda kasutatakse lastel ja noorukitel vanuses 6...17 aastat;
• It should be used as part of a treatment programme which typically includes psychological, 
• Seda tuleb kasutada osana raviprogrammist, kuhu tavaliselt kuuluvad ka psühholoogilised,
• it is not indicated in all children with ADHD. 
• see ei ole näidustatud kõikidele ATH-ga lastele;
A comprehensive treatment programme typically includes psychological, educational and social measures. 
Kompleksravi hulka kuuluvad tavaliselt psühholoogilised, pedagoogilised ja sotsiaalsed meetmeid.
4.1 Therapeutic indications [The wording of this section should read as follows] 
4.1 Näidustused [Selle lõigu tekst peab olema järgmine]
Abuse, misuse, and diversion 
Kuritarvitamine, väärkasutamine ja kõrvaletoimetamine
Dexamfetamine possesses a high potential to cause dependency and has been/is frequently abused. 
Deksamfetamiinil on suur potentsiaal sõltuvuse tekitamiseks ja seda on sageli kuritarvitatud ja kuritarvitatakse.
Diagnosis should be made according to DSM-5 criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient. 
Diagnoos peab vastama DSM-IV kriteeriumidele või RHK-10 juhendile ning tuginema patsiendi kompleksetele põhjalikele uuringutele.