FrancophonIA/ELRC3.0 huggingface dataset:
English: Ogivri was to be used only when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells, which makes the tumour cells grow more quickly.
Romanian: Ogivri urma să fie utilizat numai în cazurile în care s-a dovedit că tumoarea prezintă „supraexpresia HER2”, adică produce în cantități mari o proteină numită HER2 pe suprafața celulelor tumorale, ceea ce determină o creștere mai rapidă a acestora.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom structure (called an antigen) that is found on certain cells in the body.
Romanian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: What was Ogivri expected to be used for?
Romanian: Pentru ce ar fi trebuit să se utilizeze Ogivri?
English: Trastuzumab has been designed to attach to HER2.
Romanian: Trastuzumabul a fost conceput astfel încât să se lege de HER2.
English: How does Ogivri work?
Romanian: Cum acționează Ogivri?
English: The company informed the CHMP that the withdrawal does not impact ongoing clinical trials with Ogivri.
Romanian: Compania a informat CHMP că retragerea nu are niciun impact asupra studiilor clinice aflate în derulare cu Ogivri.
English: It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Romanian: Medicamentul urma să fie disponibil sub formă de pulbere pentru prepararea unei soluții pentru perfuzie intravenoasă (picurare în venă).
English: Based on the review of the data at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Ogivri could not have been approved for the treatment of breast cancer and gastric cancer.
Romanian: Pe baza analizării datelor, în momentul retragerii cererii CHMP avea unele motive de îngrijorare și a dat un aviz provizoriu potrivit căruia Ogivri nu putea fi aprobat pentru tratamentul cancerului de sân și al cancerului gastric.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough documentation to support the application for Ogivri.
Romanian: Prin urmare, la momentul retragerii cererii, în opinia CHMP, compania nu prezentase o documentație suficientă în sprijinul cererii pentru autorizarea Ogivri.
English: HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers.
Romanian: Aproximativ un sfert din cancerele de sân și o cincime din cancerele gastrice prezintă supraexpresia HER2.
English: Trastuzumab also stops HER2 producing signals that cause the tumour cells to grow.
Romanian: De asemenea, trastuzumabul împiedică HER2 să producă semnalele care determină creșterea celulelor tumorale.
English: officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ogivri, for the treatment of breast cancer and gastric cancer.
Romanian: La 3 august 2017, Mylan S.A.S. a informat oficial Comitetul pentru medicamente de uz uman (CHMP) că dorește să-și retragă cererea de autorizare de punere pe piață pentru Ogivri, pentru tratamentul cancerului de sân și al cancerului gastric.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because a GMP certificate for the manufacturing site of the product could not be obtained in the time available.
Romanian: În scrisoarea în care înștiințează agenția cu privire la retragerea cererii, compania a declarat că își retrage cererea din cauza imposibilității de a obține, până la termenul stabilit, un certificat BPF pentru unitatea de producție a medicamentului Ogivri.
English: Withdrawal of the marketing authorisation application for Ogivri (trastuzumab) EMA/564631/2017
Romanian: EMA/564631/2017
English: Immediate Packaging
Romanian: Mărime ambalajului
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Romanian: Forma farmaceutic ă
English: Content (concentration)
Romanian: Conţinutul
English: Annex I List of nationally authorised medicinal products
Romanian: Lista medicamentelor autorizate la nivel naţional
English: Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F.
Romanian: Aziende Chimiche Riunite Angelini Francesco - A.C.R.A.F. S.P.A.
English: Suspension For Injection
Romanian: Suspensie injectabilă
English: Nasal Drops, Suspension
Romanian: Picături nazale, suspensie
English: Oral Suspension Sublingual Use
Romanian: Suspensie orală Cale sublinguală
English: Oral Drops, Suspension
Romanian: Picături orale, suspensie
English: Oral Powder
Romanian: Pulbere orală
English: Czech Republic Om Pharma S.A.
Romanian: Republica Cehă Om Pharma S.A.
English: Luxembourg Om Pharma S.A.
Romanian: Luxemburg Om Pharma S.A.
English: Film-Coated Tablet
Romanian: Comprimate filmate
English: Laboratorio Farmaceutico S.I.T.
Romanian: Laboratorio Farmaceutico S.I.T. S.R.L.
English: Lek Pharmaceuticals D.D.
Romanian: Lek Pharmaceuticals D.D. Ljubljana
English: Intramuscular Use $
Romanian: Cale intramusculară $ Cale subcutanată
English: Powder For Oral Solution
Romanian: Pulbere pentru soluţie orală
English: Pierre Fabre Medicament Polska Sp. Z O.O.
Romanian: Pierre Fabre Medicament Polska Sp.
English: Czech Republic Pierre Fabre Medicament Ribomunyl
Romanian: Republica Cehă Pierre Fabre Medicament Ribomunyl
English: Granules For Oral Solution
Romanian: Granule pentru soluţie orală
English: Powder For Oral Suspension
Romanian: Pulbere pentru suspensie orală
English: S.P.A.
Romanian: Z O.O.
English: Granules For Oral Suspension
Romanian: Granule pentru suspensie orală
English: Streptococcus Agalactiae 1000 Mega Units Tablet, Haemophilus Influenzae 1500 Mega Units Tablet, Staphylococcus Aureus 1000 Mega Units Tablet, Streptococcus Pneumoniae 1000 Mega Units Tablet
Romanian: Streptococcus Agalactiae 1000 megaunităţi comprimate, Haemophilus Influenzae 1500 megaunităţi comprimate, Staphylococcus Aureus 1000 megaunităţi comprimate, Streptococcus Pneumoniae 1000 megaunităţi comprimate
English: 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
Romanian: Streptococcus Agalactiae 1 gigaunitate comprimate, Haemophilus Influenzae 1,5 gigaunităţi comprimate, Staphylococcus Aureus 1 gigaunitate comprimate, Streptococcus Pneumoniae 1 gigaunitate comprimate
English: Gastro-Resistant Tablet
Romanian: Comprimate gastrorezistente
English: 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
Romanian: Haemophilus Influenzae Tip B (hib) 0,625 gigacelule/25 mg, Branhamella Catarrhalis lizat 0,625 gigacelule/25 mg, Klebsiella Pneumoniae (inactivat) 0,625 gigacelule/25 mg, Staphylococcus Aureus bacterii inactivate 0,625 gigacelule/25 mg, Streptococcus Pneumoniae bacterii inactivate 0,625 gigacelule/25 mg, Streptococcus Pyogenes bacterii inactivate 0,625 gigacelule/25 mg
English: 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
Romanian: Haemophilus Influenzae Tip B (hib) 1,25 gigacelule/50 mg, Branhamella Catarrhalis lizat 1,25 gigacelule/50 mg, Klebsiella Pneumoniae (inactivat) 1,25 gigacelule/50 mg, Staphylococcus Aureus bacterii inactivate 1,25 gigacelule/50 mg, Streptococcus Pneumoniae bacterii inactivate 1,25 gigacelule/50 mg, Streptococcus Pyogenes bacterii inactivate 1,25 gigacelule/50 mg
English: Sublingual Tablet Sublingual Use
Romanian: Comprimate sublinguale
English: Czech Republic Daiichi Sankyo Europe Gmbh
Romanian: Republica Cehă Daiichi Sankyo Europe Gmbh
English: Granules
Romanian: Granule
English: 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
Romanian: Escherichia Coli (inactivat) 20 megacelule/Ml, Klebsiella Pneumoniae (inactivat) 10 megacelule/Ml, Staphylococcus Aureus bacterii inactivate 50 megacelule/Ml, Staphylococcus Epidermidis bacterii inactivate 50 megacelule/Ml, Streptococcus Salivarius bacterii inactivate 10 megacelule/Ml, Streptococcus Pneumoniae bacterii inactivate 10 megacelule/Ml, Streptococcus Pyogenes bacterii inactivate 10 megacelule/Ml, Haemophilus Influenzae bacterii inactivate 10 megacelule/Ml, Corynebacterium Pseudodiphtheriticum bacterii inactivate 20 megacelule/Ml, Moraxella Catarrhalis bacterii inactivate 10 megacelule/Ml
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Sachet
Romanian: Broncho-Vaxom Lizate bacteriene liofilizate 3,5 mg plicuri
English: 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
Romanian: Proteoglicani de Klebsiella Pneumoniae 1,125 mg plicuri, Fracţiuni ribozomale (ribozomi cu un titru de ARN de 70%) 0,75 mg plicuri, Ribozomi de Haemophilus Influenzae 5 unităţi plicuri, Ribozomi de Streptococcus Pneumoniae 30 unităţi plicuri, Fracţiuni ribozomale de Klebsiella Pneumoniae 35 unităţi plicuri, Riboszomi de la Streptococcus Pyogenes Grupa A 30 unităţi plicuri
English: Lysatum Bacteriale Mixtum 3mg Tablet
Romanian: Lysatum Bacteriale Mixtum 3 mg comprimate
English: Broncho-Vaxom Lyophilized Bacterial Lysates 3.5mg Capsule
Romanian: Broncho-Vaxom Lizate bacteriene liofilizate 3,5 mg capsule
English: 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
Romanian: Escherichia Coli (inactivat) 2 megacelule/Ml, Klebsiella Pneumoniae (inactivat) 1 megacelule/Ml, Staphylococcus Aureus bacterii inactivate 5 megacelule/Ml, Staphylococcus Epidermidis bacterii inactivate 5 megacelule/Ml, Streptococcus Salivarius bacterii inactivate 1 megacelule/Ml, Streptococcus Pneumoniae bacterii inactivate 1 megacelule/Ml, Streptococcus Pyogenes bacterii inactivate 1 megacelule/Ml, Haemophilus Influenzae bacterii inactivate 1 megacelule/Ml, Corynebacterium Pseudodiphtheriticum bacterii inactivate 2 megacelule/Ml, Moraxella Catarrhalis bacterii inactivate 1 megacelule/Ml
English: Luxembourg Daiichi Sankyo Europe Gmbh
Romanian: Luxemburg Daiichi Sankyo Europe Gmbh
English: 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
Romanian: Escherichia Coli (inactivat) 200 megacelule/Ml, Klebsiella Pneumoniae (inactivat) 100 megacelule/Ml, Staphylococcus Aureus bacterii inactivate 500 megacelule/Ml, Staphylococcus Epidermidis bacterii inactivate 500 megacelule/Ml, Streptococcus Salivarius bacterii inactivate 100 megacelule/Ml, Streptococcus Pneumoniae bacterii inactivate 100 megacelule/Ml, Streptococcus Pyogenes bacterii inactivate 100 megacelule/Ml, Haemophilus Influenzae bacterii inactivate 100 megacelule/Ml, Corynebacterium Pseudodiphtheriticum bacterii inactivate 200 megacelule/Ml, Moraxella Catarrhalis bacterii inactivate 100 megacelule/Ml
English: Standardized Lyophylisate Of Bacterial Lysates 7mg Capsule
Romanian: Liofilizat standardizat de lizate bacteriene 7 mg capsule
English: Lyophilised, Standardised Bacterial Extract 7mg Capsule
Romanian: Extract bacterian liofilizat standardizat 7 mg capsule
English: 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
Romanian: Haemophilus Influenzae Tip 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
English: Broncho-Vaxom Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Romanian: Broncho-Vaxom Extract bacterian liofilizat standardizat 3,5 mg capsule
English: Lyophilised, Standardised Bacterial Extract 3.5mg Capsule
Romanian: Extract bacterian liofilizat standardizat 3,5 mg capsule
English: Haemophilus Influenzae Type B (Hib) 50.2agu/Ml, Klebsiella Pneumoniae 39.8agu/Ml, Staphylococcus Aureus 79.6agu/Ml, Streptococcus Pneumoniae 63.2dagu/Ml, Streptococcus Pyogenes 126.2agu/Ml, Moraxella Catarrhalis 39.9agu/Ml
Romanian: Haemophilus Influenzae Tip B (hib) 50,2 agu/Ml, Klebsiella Pneumoniae 39,8 agu/Ml, Staphylococcus Aureus 79,6 agu/Ml, Streptococcus Pneumoniae 63,2 dagu/Ml, Streptococcus Pyogenes 126,2 agu/Ml, Moraxella Catarrhalis 39,9 agu/Ml
English: Standardized Lyophylisate Of Bacterial Lysates 3.5mg Capsule
Romanian: Liofilizat standardizat de lizate bacteriene 3,5 mg capsule
English: 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
Romanian: Fracţiuni membranare de Klebsiella Pneumoniae 15 unităţi/Ml, Ribozomi de Haemophilus Influenzae 0,5 unităţi/Ml, Ribozomi de Streptococcus Pneumoniae 3 unităţi/Ml, Fracţiuni ribozomale de Klebsiella Pneumoniae 3,5 unităţi/Ml, Ribozomi din Streptococcus Pyogenes Grupa A 3 unităţi/Ml
English: Lyophilized Bacterial Lysates 7mg Capsule
Romanian: Lizat bacterian liofilizat 7 mg capsule
English: Broncho Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Romanian: Broncho Vaxom Lizate bacteriene liofilizate 7 mg capsule
English: 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
Romanian: Proteoglicani de Klebsiella Pneumoniae 1,125 mg plicuri, Ribozomi de Haemophilus Influenzae 5 unităţi plicuri, Ribozomi de Streptococcus Pneumoniae 30 unităţi plicuri, Fracţiuni ribozomale de Klebsiella Pneumoniae 35 unităţi plicuri, Ribozomi de la Streptococcus Pyogenes Gropa A 30 unităţi plicuri
English: Lyophilized Bacterial Lysates 3.5mg Capsule
Romanian: Lizat bacterian liofilizat 3,5 mg capsule
English: 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
Romanian: Glicină 43 mg comprimate Haemophilus Influenzae () 6 gigaorganisme comprimate, Klebsiella Ozaenae 6 gigaorganisme comprimate, Klebsiella Pneumoniae 6 gigaorganisme comprimate, Neisseria Catarrhalis 6 gigaorganisme comprimate, Staphylococcus Aureus 6 gigaorganisme comprimate, Streptococcus Pneumoniae 6 gigaorganisme comprimate, Streptococcus Pyogenes 6 gigaorganisme comprimate, Streptococcus Oralis 6 gigaorganisme comprimate, Lizate bacteriene liofilizate 50 mg comprimate
English: Subcutaneous Use
Romanian: Cale sublinguală
English: 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
Romanian: Glicină 43 mg comprimate Haemophilus Influenzae () 6 gigaorganisme comprimate, Klebsiella Ozaenae 6 gigaorganisme comprimate, Klebsiella Pneumoniae 6 gigaorganisme comprimate, Neisseria Catarrhalis 6 gigaorganisme comprimate, Staphylococcus Aureus 6 gigaorganisme comprimate, Streptococcus Pneumoniae 6 gigaorganisme comprimate, Streptococcus Pyogenes 6 gigaorganisme comprimate, Streptococcus Viridans 6 gigaorganisme comprimate, Lizate bacteriene liofilizate 50 mg comprimate
English: 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
Romanian: Haemophilus Influenzae 6 gigacelule comprimate, Klebsiella Ozaenae 6 gigacelule comprimate, Klebsiella Pneumoniae 6 gigacelule comprimate, Neisseria Catarrhalis 6 gigacelule comprimate, Staphylococcus Aureus 6 gigacelule comprimate, Streptococcus Pneumoniae 6 gigacelule comprimate, Streptococcus Pyogenes 6 gigacelule comprimate, Streptococcus Oralis 6 gigacelule comprimate
English: Broncho-Vaxom Lyophilized Bacterial Lysates 7mg Capsule
Romanian: Broncho-Vaxom Lizate bacteriene liofilizate 7 mg capsule
English: Lyophilized Bacterial Lysates 7mg Tablet
Romanian: Lizate bacteriene liofilizate 7 mg comprimate
English: Lyophilized Bacterial Lysates 3.5mg Sachet
Romanian: Lizate bacteriene liofilizate 3,5 mg plicuri
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 7mg Capsule
Romanian: Extract bacterian uscat prin congelare (lliofilizat) standardizat 7 mg capsule
English: 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
Romanian: Haemophilus Influenzae 6 gigacelule comprimate, Klebsiella Ozaenae 6 gigacelule comprimate, Klebsiella Pneumoniae 6 gigacelule comprimate, Neisseria Catarrhalis 6 gigacelule comprimate, Staphylococcus Aureus 6 gigacelule comprimate, Streptococcus Pneumoniae 6 gigacelule comprimate, Streptococcus Pyogenes 6 gigacelule comprimate, Streptococcus Viridans 6 gigacelule comprimate
English: Lysatum Bacteriale Mixtum 3.5mg Sachet
Romanian: Lysatum Bacteriale Mixtum 3,5 mg plicuri
English: 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
Romanian: Fracţiuni membranare de Klebsiella Pneumoniae 15 unităţi, Ribozomi de Haemophilus Influenzae 0,5 unităţi, Ribozomi de Streptococcus Pneumoniae 3 unităţi, Fracţiuni ribozomale de Klebsiella Pneumoniae 3,5 unităţi, Ribozomi din Streptococcus Pyogenes Grupa A 3 unităţi
English: Bacterial Lysate 3.5mg Capsule
Romanian: Lizate bacteriene liofilizate 3,5 mg capsule
English: Bacterial Lysate 7mg Capsule
Romanian: Lizate bacteriene liofilizate 7 mg capsule
English: Freeze-Dried (Lyophilised), Standardised Bacterial Lysate 3.5mg Capsule
Romanian: Extract bacterian uscat prin congelare (lliofilizat) standardizat 3,5 mg capsule
English: 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
Romanian: Fracţiuni membranare de Klebsiella Pneumoniae 15 unităţi comprimate, Ribozomi de Haemophilus Influenzae 0,5 unităţi comprimate, Ribozomi de Streptococcus Pneumoniae 3 unităţi, Fracţiuni ribozomale de Klebsiella Pneumoniae 3,5 unităţi comprimate, Ribozomi de la Streptococcus Pyogenes Grupa A 3 unităţi comprimate
English: MA (EU) number (Invented) name
Romanian: Numărul (UE) APP Numele
English: 18 June 2012
Romanian: 18 iunie 2012
English: Article 34 of Directive 2001/82/EC, as amended
Romanian: Articolul 34 din Directiva 2001/82/CE, astfel cum a fost modificată
English: The final opinion was converted into a Decision by the European Commission on 18 June 2012.
Romanian: Avizul final a devenit decizie a Comisiei Europene la 18 iunie 2012.
English: The referral procedure started on 14 September 2011.
Romanian: Procedura de sesizare a fost iniţiată la 14 septembrie 2011.
English: These veterinary medicinal products are intended for the treatment of various parasitic infections in dogs caused by nematodes and cestodes.
Romanian: Aceste produse medicamentoase veterinare sunt destinate tratamentului diferitelor infecţii parazitare cauzate de nematode şi cestode la câini.
English: The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Romanian: Comitetul l-a numit raportor pe dr. Michael Holzhauser-Alberti şi coraportor pe dr. David Murphy.
English: Written explanations were provided by the marketing authorisation holder on 2 December 2011.
Romanian: Titularul autorizaţiei de introducere pe piaţă a prezentat explicaţii scrise la 2 decembrie 2011.
English: 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.
Romanian: Lista denumirilor produselor în cauză este prezentată în anexa I. Concluziile ştiinţifice sunt prezentate în anexa II, iar Rezumatul caracteristicilor produsului, etichetarea şi prospectul modificate în anexa III.
English: Febantel is a probenzimidazole.
Romanian: Febantel este un probenzimidazol.
English: Praziquantel is a partially hydrogenated pyrazinoisoquinoline derivative.
Romanian: Praziquantel este un derivat de pyrazinoisoquinolină parţial hidrogenat.
English: International non-proprietary name (inn): Praziquantel, pyrantel and febantel
Romanian: Denumirea comună internaţională(DCI): praziquantel, pyrantel şi febantel Informaţii de bază