FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common side effects with CellCept used in combination with ciclosporin and corticosteroids (seen in more than 1 patient in 10) are sepsis (blood infection), gastrointestinal candidiasis (a fungal infection of the stomach or gut), urinary tract infection (infection of the structures that carry urine), herpes simplex (a viral infection that causes cold sores), herpes zoster (a viral infection that causes chickenpox and shingles), leucopenia (low white blood cell counts), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), vomiting, abdominal (tummy) pain, diarrhoea and nausea (feeling sick).
Latvian: Visbiežāk novērotās nevēlamās CellCept blakusparādības, lietojot šīs zāles kopā ar ciklosporīnu un kortikosteroīdiem, (vairāk nekā 1 pacientam no 10) ir sepse (asins infekcija), kuņģa un zarnu trakta kandidiāze (kuņģa vai zarnu sēnīšu infekcija), urīnceļu infekcija (infekcija urīnu pārvadošās struktūrās), parastais herpess (vīrusu infekcija, kas izsauc vienkāršo pūslīšēdi), jostas roze (vīrusu infekcija, kas izraisa vējbakas un jostas rozi), leikopēnija (mazs balto asins šūnu skaits),
English: The way that CellCept should be given and the dose depend on the type of organ transplant and the patient's age and size.
Latvian: CellCept lietošanas veids un deva ir atkarīgi no pārstādītā orgāna veida, pacienta vecuma un auguma.
English: By preventing the production of new DNA, CellCept reduces the rate at which the lymphocytes multiply.
Latvian: Novēršot jaunas DNS veidošanos, CellCept samazina limfocītu vairošanās ātrumu.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for CellCept.
Latvian: Tajā ir paskaidrots, kā Cilvēkiem paredzēto zāļu komiteja (CHMP) novērtēja šīs zāles, pirms sniegt pozitīvu atzinumu par reģistrācijas apliecības piešķiršanu un ieteikumus par CellCept lietošanu.
English: In children undergoing kidney transplants, the rejection rates were similar to those seen in adults taking CellCept and lower than those seen in other studies of children who did not receive CellCept.
Latvian: Bērniem, kuriem veica nieru pārstādīšanu, tremes biežums bija līdzīgs kā pieaugušajiem, kuri lietoja CellCept, un mazāks par to, ko novēroja bērniem citos pētījumos, kuru laikā viņi nesaņēma CellCept.
English: The CHMP decided that CellCept's benefits are greater than its risks and recommended that it be given marketing authorisation.
Latvian: CHMP nolēma, ka pacienta ieguvums, lietojot CellCept, pārsniedz šo zāļu radīto risku, un ieteica izsniegt CellCept reģistrācijas apliecību.
English: Safety information has also been included in the summary of product characteristics and the package leaflet for CellCept, including the appropriate precautions to be followed by healthcare professionals and patients.
Latvian: Zāļu aprakstā ir ietverta arī drošuma informācija, kā arī CellCept lietošanas instrukcija, tostarp, attiecīgi piesardzības pasākumi, kas jāievēro veselības aprūpes speciālistiem un pacientiem.
English: The dose may need to be adjusted in patients with liver or kidney disease.
Latvian: Pacientiem ar aknu vai nieru darbības traucējumiem var būt vajadzīga devas pielāgošana.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom between two and 18 years, the dose of CellCept is calculated depending on height and weight and should be given by mouth.
Latvian: 30 Churchill Place ● Canary Wharf ● Londona E14 5EU ● Apvienotā Karaliste
English: In the body, it is converted into mycophenolic acid, which blocks an enzyme called ‘inosine monophosphate dehydrogenase'.
Latvian: Organismā tās tiek pārvērstas par mikofenolskābi, kas bloķē fermenta inozīnmonofosfātdehidrogenāzi.
English: Following liver transplant, 38% of the adult patients taking CellCept had rejected their new liver after six months, compared with 48% of those taking azathioprine, but the proportion of patients who had lost their new liver after a year was similar in the two groups, at around 4%.
Latvian: Sešus mēnešus pēc aknu transplantēšanas 38 % pacientu, kuri lietoja CellCept, novēroja pārstādīto aknu tremi, salīdzinot ar 48 % pacientu, kuri lietoja azatioprīnu, bet pēc gada to pacientu daļa, kuriem novēroja pārstādīto aknu tremi, abās grupās bija līdzīga - ap
English: There will also be very close monitoring of the outcomes of any accidentally exposed pregnancies.
Latvian: Turklāt tiks veikta stingra uzraudzība attiecībā uz tādu grūtniecību iznākumiem, kuru laikā šīs zāles tika netīšām lietotas.
English: Why has CellCept been approved?
Latvian: Kāpēc CellCept tika apstiprinātas?
English: For kidney transplants, the recommended dose in adults is 1 g twice a day by mouth (capsules, tablets or oral suspension) starting within 72 hours after the transplant.
Latvian: Nieru transplantēšanas gadījumā ieteicamā deva pieaugušajiem ir 1 g divreiz dienā iekšķīgi (kapsulas, tabletes vai suspensija iekšķīgai lietošanai), ko sāk lietot 72 stundu laikā pēc transplantācijas.
English: What benefit has CellCept shown during the studies?
Latvian: Kādas bija CellCept priekšrocības šajos pētījumos?
English: CellCept is a medicine containing the active substance mycophenolate mofetil.
Latvian: CellCept ir zāles, kas satur aktīvo vielu mikofenolātmofetilu.
English: In the heart transplant study, around 38% of adult patients taking CellCept and those taking azathioprine experienced rejection after six months.
Latvian: Sirds transplantācijas pētījumā pēc sešiem mēnešiem treme notika ap 38 % pacientu, kuri lietoja CellCept un kuri lietoja azatioprīnu.
English: CellCept mycophenolate mofetil
Latvian: CellCept mikofenolātmofetils
English: For heart transplants, the recommended adult dose is 1.5 g twice a day by mouth, starting within five days following the transplant.
Latvian: Sirds transplantācijas gadījumā ieteicamā deva pieaugušajiem ir 1,5 g divreiz dienā iekšķīgi, sākot ievadīt piecu dienu laikā pēc transplantācijas.
English: For liver transplants in adults, CellCept should be given as a 1-g infusion twice a day for the first four days after the transplant, before the patient is switched to 1.5 g twice a day by mouth as soon as it can be tolerated.
Latvian: Aknu transplantācijas gadījumā pieaugušajiem CellCept ir jāievada ar infūziju divreiz dienā pa 1 g pirmās četras dienas pēc transplantācijas, pēc tam devu nomaina uz 1,5 g divreiz dienā iekšķīgi, tiklīdz tā ir panesama.
English: CellCept is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Latvian: CellCept lieto, lai novērstu nieres, sirds vai aknu tremi pēc transplantācijas.
English: The active substance in CellCept, mycophenolate mofetil, is an immunosuppressive medicine.
Latvian: CellCept aktīvā viela mikofenolātmofetils ir imūnsupresīvas zāles.
English: What is the risk associated with CellCept?
Latvian: Kāds risks pastāv, lietojot CellCept?
English: What is CellCept?
Latvian: Kas ir CellCept?
English: In children aged
Latvian: Eiropas Savienības aģentūra
English: For the full list of side effects reported with CellCept, see the package leaflet.
Latvian: Pilns visu CellCept izraisīto blakusparādību saraksts ir atrodams zāļu lietošanas instrukcijā.
English: How does CellCept work?
Latvian: Kā CellCept darbojas?
English: In all of the studies, all of the patients also received ciclosporin and corticosteroids, and the main measure of effectiveness was the proportion of patients whose new organ had been rejected after six months.
Latvian: Visos pētījumos visi pacienti saņēma arī ciklosporīnu un kortikosteroīdus.
English: How is CellCept used?
Latvian: Kā lieto CellCept?
English: How has CellCept been studied?
Latvian: Kā noritēja CellCept izpēte?
English: For full details of the restrictions with CellCept, see the package leaflet.
Latvian: Informācija par CellCept lietošanas ierobežojumiem ir atrodama zāļu lietošanas instrukcijā.
English: What is CellCept used for?
Latvian: Kāpēc lieto CellCept?
English: MA (EU) number
Latvian: (ES) numurs Piešķirtais nosaukums
English: Immediate Packaging
Latvian: Ievadīšanas veids Tiešais Iepakojums
English: Suspension: 1.5 ml Emulsion: 4.5 ml
Latvian: suspensija : 1,5 ml emulsija : 4,5 ml
English: 3.8 micrograms HA**
Latvian: 3,8 mikrogramiem**
English: Split Influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)
Latvian: Inaktivētu, šķeltu gripas vīrusu, kas satur antigēnu*, kas ekvivalents A/California/7/2009 (H1N1)-tipa celma (X-179A)
English: 10 vials (suspension)
Latvian: 10 flakoni (suspensija )
English: AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Latvian: Adjuvants AF03, kura sastāvā ir skvalēns (12,4 miligrami), sorbitāna oleāta (1,9 miligrami), polioksietilēna cetostearilētera (2,4 miligrami) un mannitola (2,3 miligrami).
English: 10 vials (emulsion)
Latvian: 10 flakoni (emulsija)
English: 3.8 µg HA
Latvian: 3,8 mikrogrami HA
English: Suspension (H1N1): vial (glass);
Latvian: Intramuskulāra lietošana suspensija (H1N1): flakons (stikla)
English: Emulsion (adjuvant): vial (glass)
Latvian: emulsija (adjuvants): flakons (stikla)
English: After mixing, 1 dose (0.5 ml) contains:
Latvian: 1 deva (0,5 ml) pēc sajaukšanas satur:
English: * propagated in eggs ** haemagglutinin
Latvian: * pavairots olās ** hemaglutinīna
English: Content
Latvian: v
English: This summary was last updated in 04-2014.
Latvian: Šo kopsavilkumu pēdējo reizi atjaunināja 04.2014.
English: The full EPAR and risk management plan summary for BiResp Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Latvian: Pilns BiResp Spiromax EPAR teksts un riska pārvaldības plāna kopsavilkums ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Latvian: Ja pacientam nepieciešams lietot vairāk par 8 inhalācijām dienā, ieteicams konsultēties ar savu ārstu par terapijas pārskatīšanu.
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Latvian: Tāpēc CHMP uzskatīja, ka, tāpat kā Symbicort Turbohaler gadījumā, ieguvumi pārsniedz identificēto risku.
English: Formoterol is a long-acting beta-2 agonist.
Latvian: Formoterols ir ilgstošas darbības β2 agonists.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
Latvian: Tas nozīmē, ka šīs zāles ir līdzīgas “atsauces zālēm”, kas satur tās pašas aktīvās vielas, bet BiResp Spiromax tiek lietotas ar cita veida inhalatoru.
English: It can also be used for the treatment of COPD.
Latvian: Šīs zāles var lietot arī HOPS ārstēšanai.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Latvian: Šīs zāles var lietot pacientiem, kuru slimība netiek pietiekami kontrolēta ar citām astmas zālēm, t.i., inhalējamiem kortikosteroīdiem un “īslaicīgas darbības β2 agonistiem”, vai pacientiem, kuru slimība tiek pietiekami kontrolēta, lietojot gan inhalējamos kortikosteroīdus, gan “ilgstošas darbības β2 agonistus”.
English: It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Latvian: Tās ir paredzētas astmas ārstēšanai pieaugušajiem, kuriem ir piemērota kombinēta zāļu lietošana.
English: This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
Latvian: Šis ir Eiropas Publiskā novērtējuma ziņojuma (EPAR) kopsavilkums par BiResp Spiromax.
English: What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
Latvian: Kas tiek darīts, lai nodrošinātu nekaitīgu un efektīvu BiResp Spiromax lietošanu?
English: BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Latvian: Zāles BiResp Spiromax ir paredzētas arī smagu hronisku obstruktīvu plaušu slimību (HOPS) simptomu ārstēšanai pieaugušajiem, kuriem anamnēzē ir atkārtoti slimības paasinājumi, neskatoties uz regulāru terapiju.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
Latvian: HOPS ir ilgstoša slimība, kuras gadījumā elpceļi un gaisa maisi plaušās tiek bojāti vai nosprostojas, radot grūtības ieelpot un izelpot gaisu.
English: The company initially also applied for a lower strength of BiResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Latvian: Sākotnēji uzņēmums iesniedza pieteikumu mazākai BiResp Spiromax devai, tomēr bioekvivalence ar atsauces zālēm netika pierādīta, tādēļ pieteikums tika atsaukts.
English: BiResp Spiromax budesonide / formoterol
Latvian: BiResp Spiromax budezonīds/formoterols
English: The two active substances in BiResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Latvian: Divas BiResp Spiromax aktīvās vielas ir labi zināmas un tiek izmantotas vairākās zālēs, ko lieto astmas un HOPS ārstēšanai gan atsevišķi, gan kopā ar citām zālēm.
English: A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
Latvian: Lai nodrošinātu iespējami nekaitīgu BiResp Spiromax lietošanu, ir izstrādāts riska pārvaldības plāns.
English: It is not intended to provide practical advice on how to use BiResp Spiromax.
Latvian: Tas nav paredzēts kā praktiski ieteikumi par BiResp Spiromax lietošanu.
English: Because BiResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Latvian: Tā kā BiResp Spiromax ir hibrīdas zāles un bioekvivalentas atsauces zālēm, to ieguvumu un riska attiecību uzskata par līdzvērtīgu atsauces zāļu ieguvumu un riska attiecībai.
English: BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Latvian: BiResp Spiromax ir zāles, kas satur aktīvās vielas budezonīdu un formoterolu.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Latvian: Tas ierobežo iekaisuma procesā iesaistīto vielu, piemēram, histamīna, izdalīšanos, tādējādi atverot pacienta elpceļus un atvieglojot elpošanu.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Latvian: Eiropas Komisija 2014. gada 28. aprīlī izsniedza BiResp Spiromax reģistrācijas apliecību, kas derīga visā Eiropas Savienībā.
English: For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Latvian: Lai iegūtu praktisku informāciju par BiResp Spiromax lietošanu, pacientiem jāizlasa zāļu lietošanas instrukcija vai jāsazinās ar ārstu vai farmaceitu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
Latvian: Pamatojoties uz šo plānu, BiResp Spiromax zāļu aprakstā ietverta drošuma informācija, kā arī lietošanas instrukcija, tostarp attiecīgi piesardzības pasākumi, kas jāievēro veselības aprūpes speciālistiem un pacientiem.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Latvian: Aģentūras Cilvēkiem paredzēto zāļu komiteja (CHMP) secināja, ka saskaņā ar ES prasībām BiResp Spiromax 160/4,5 mikrogramu un 320/9 mikrogramu devai un attiecīgai Symbicort Turbohaler devai ir pierādīta kvalitātes līdzvērtība un bioekvivalence.
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Latvian: Budezonīds pieder pretiekaisuma līdzekļu grupai, ko sauc par kortikosteroīdiem.
English: The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
Latvian: BiResp Spiromax atsauces zāles ir Symbicort Turbohaler.
English: Other information about BiResp Spiromax
Latvian: Cita informācija par BiResp Spiromax
English: As asthma reliever therapy, patients can take 1 or 2 additional inhalations of BiResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Latvian: Kā astmas glābšanas terapiju - tikai simptomu atvieglošanaipacienti var lietot papildu 1 vai 2 inhalācijas ar 160/4,5 mikrogramu BiResp Spiromax devu.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Latvian: Tas iedarbojas, piesaistoties elpceļu muskuļu receptoriem, ko sauc par β2 receptoriem.
English: For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Latvian: Plašāka informācija par ārstēšanu ar BiResp Spiromax atrodama zāļu lietošanas instrukcijā (kas arī ir EPAR daļa) vai sazinoties ar ārstu vai farmaceitu.
English: What is BiResp Spiromax and what is it used for?
Latvian: Kas ir BiResp Spiromax un kāpēc tās lieto?
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Latvian: Budezonīds samazina imūnsistēmas aktivitāti, piesaistoties dažādu imūnsistēmas šūnu veidu receptoriem.
English: BiResp Spiromax is a ‘hybrid medicine'.
Latvian: BiResp Spiromax ir “hibrīdas zāles”.
English: Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Latvian: Pētījumos ar pacientiem veica tikai testus, lai pierādītu, ka šīs zāles un atsauces zāles Symbicort Turbohaler ir bioekvivalentas.
English: The Committee recommended that BiResp Spiromax be given marketing authorisation.
Latvian: Komiteja ieteica izsniegt BiResp Spiromax reģistrācijas apliecību.
English: For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
Latvian: Atkarībā no devas stipruma HOPS ārstēšanai ieteicamā deva ir 1 vai 2 inhalācijas divreiz dienā.
English: Why is BiResp Spiromax approved?
Latvian: Kāpēc BiResp Spiromax tika apstiprinātas?
English: What are the benefits and risks of BiResp Spiromax?
Latvian: Kāda ir BiResp Spiromax ieguvumu un riska attiecība?
English: The higher strength, BiResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Latvian: Regulārai astmas ārstēšanai un simptomu atvieglošanai var lietot 320/9 mikrogramu devu (320 mikrogrami budezonīda un 9 mikrogrami formoterola).
English: For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Latvian: Atkarībā no devas stipruma un astmas smaguma pakāpes regulārai astmas ārstēšanai ieteicamā deva ir 1-4 inhalācijas divreiz dienā.
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Latvian: Regulārai astmas ārstēšanai un simptomu atvieglošanai var lietot 160/4,5 mikrogramu devu (160 mikrogrami budezonīda un 4,5 mikrogrami formoterola).
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Latvian: Piesaistoties šiem receptoriem, tas atslābina muskuļus.
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Latvian: Šīs zāles ir pieejamas inhalācijas pulvera veidā, kas ir iepildīts pārnēsājamā inhalatorā.
English: How does BiResp Spiromax work?
Latvian: Kā BiResp Spiromax darbojas?
English: How has BiResp Spiromax been studied?
Latvian: Kā noritēja BiResp Spiromax izpēte?
English: How is BiResp Spiromax used?
Latvian: Kā lieto BiResp Spiromax?
English: For further information, see the package leaflet.
Latvian: Plašāku informāciju skatiet lietošanas instrukcijā.
English: Ref. EMEA/490683/2006
Latvian: EMEA/490683/2006
English: The company presented the results of 2 main studies including 1065 patients.
Latvian: Uzņēmums iesniedza rezultātus no diviem galvenajiem pētījumiem, kuros bija iesaistīti 1065 pacienti.
English: London, 14 December 2006 Doc.
Latvian: Londona, 2006. gada 14. decembris Dok. ref.
English: What is Synordia?
Latvian: Kas ir Synordia?
English: Around half of the patients in this study had type 2 diabetes.
Latvian: Apmēram pusei pacientu šajā pētījumā bija 2. tipa diabēts.
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Latvian: Saskaņā ar CHMP atzinumu Eiropas Komisijai licences izsniegšanai parasti ir nepieciešami 2 mēneši.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Latvian: Ja esat iesaistīts pašreiz notiekošajā klīniskajā izpētē un Jums ir vajadzīga plašāka informācija par Jūsu ārstēšanu, kontaktējieties ar savu ārstējošo ārstu.
English: How far into the evaluation was the application when it was withdrawn?
Latvian: Cik tālu bija pavirzījusies pieteikuma izvērtēšana, kad tas tika atsaukts?
English: The tablets contain 80 mg fenofibrate and 500 mg metformin, 80 mg fenofibrate and 850 mg metformin, or 54 mg fenofibrate and 850 mg metformin.
Latvian: Tabletes satur 80 mg fenofibrāta un 500 mg metformīna; 80 mg fenofibrāta un 850 mg metformīna vai 54 mg fenofibrāta un 850 mg metformīna.
English: This receptor is normally involved in controlling levels of fat in the body.
Latvian: Šis receptors parasti ir iesaistīts organisma tauku līmeņa kontrolē.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Latvian: (44-20) 74 18 84 00 Fax (44-20) 75 23 71 29 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Latvian: Tiklīdz uzņēmums ir iesniedzis atbildes uz šiem jautājumiem, CHMP izskata tās un, pirms izsniegt atzinumu, uzdod pārējos jautājumus (180. dienā).
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SYNORDIA
Latvian: JAUTĀJUMI UN ATBILDES PAR REĢISTRĀCIJAS APLIECĪBAS PIETEIKUMA ATSAUKŠANU ZĀLĒM SYNORDIA
English: The doses were the same as the 3 doses available in Synordia tablets.
Latvian: Šīs devas bija tādas pašas, kā tās 3 devas, kas pieejamas Synordia tabletēs.