natgillin/translations-raw huggingface dataset:
Uncommon: asthenia, headache
Občasno: astenija, glavobol
Talk to your doctor before taking Vedrop if you have:
Posvetujte se z zdravnikom preden vzamete zdravilo Vedrop, če imate: Težave z ledvicami ali dehidracijo.
Not known: abdominal pain
Pogosto: diareja Ni znano: bolečine v trebuhu
Excipients: sodium methyl parahydroxybenzoate (E219), sodium ethyl parahydroxybenzoate (E215).
Pomožne snovi: Natrijev metilparahidroksibenzoat (E219), natrijev etilparahidroksibenzoat (E215).
Potassium sorbate
peroralna raztopina
How to store Vedrop
Shranjevanje zdravila Vedrop
Boxes containing: one 10 ml bottle and one 1 ml oral syringe one 20 ml bottle and one 1 ml oral syringe one 60 ml and one 2 ml oral syringe
eno 10 ml steklenico in eno 1 ml brizgo za peroralno uporabo eno 20 ml steklenico in eno 1 ml brizgo za peroralno uporabo eno 60 ml steklenico in eno 2 ml brizgo za peroralno uporabo
2- Put the oral syringe included in the pack in the bottle.
2- Vstavite brizgo v steklenico.
Bottle of 60 ml and 2 ml oral syringe.
60 ml steklenica in 2 ml brizga za peroralno uporabo.
Each ml contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
En ml vsebuje 50 mg d-alfa-tokoferola v obliki tokofersolana, kar ustreza 74,5 i.e. tokoferola.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Bottle label - 10 ml, 20 ml and 60 ml bottles
Nalepka na steklenici - 10 ml, 20 ml in 60 ml steklenica
The bottles contain 10 ml, 20 ml or 60 ml of oral solution.
Steklenica vsebuje 10 ml, 20 ml ali 60 ml peroralne raztopine.
Each ml of solution contains 50 mg of d-alpha-tocopherol in the form of tocofersolan, corresponding to 74.5 IU of tocopherol.
En ml vsebuje 50 mg d-alfa-tokoferola v obliki tokofersolana, ki ustreza 74,5 i.e. tokoferola.
Each bottle contains 10 ml, 20 ml or 60 ml of oral solution.
Ena steklenica vsebuje 10 ml, 20 ml ali 60 ml peroralne raztopine.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box - 10 ml, 20 ml and 60 ml bottle
Kartonska škatla - 10 ml, 20 ml in 60 ml steklenica
Bottle of 20 ml and 1 ml oral syringe.
20 ml steklenica in 1 ml brizga za peroralno uporabo.
Bottle of 10 ml and 1 ml oral syringe.
10 ml steklenica in 1 ml brizga za peroralno uporabo.
Taken up by cells, the alpha-tocopherol moiety appears in chylomicrons in the lymph in a manner identical to vitamin E absorbed from the diet. Cellular uptake does not require receptors, binding proteins or metabolic processes and does not occur by pinocytosis.
Celični prevzem ne potrebuje receptorjev, veznih proteinov ali presnovnih procesov in se ne zgodi z pinocitozo.
Skin and subcutaneous tissue disorders Uncommon: alopecia, pruritus, rash General disorders and administration site conditions
Občasno: alopecija, pruritus, osip
Sodium methyl parahydroxybenzoate (E219) Sodium ethyl parahydroxybenzoate (E215) Glycerol
6.1 Seznam pomožnih snovi kalijev sorbat natrijev metilparahidroksibenzoat (E219) natrijev etilparahidroksibenzoat (E215) glicerol natrijev hidrogenfosfat dodekahidrat koncentrirana klorovodikova kislina prečiščena voda
The following side effects were reported:
Škatle vsebujejo:
Marketing Authorisation Holder Recordati Rare Diseases Immeuble “Le Wilson” 70 avenue du General de Gaulle 92800 Puteaux
Imetnik dovoljenja za promet z zdravilom Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux France or
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux Francija
One graduation of the 1 ml oral syringe corresponds to 2.5 mg of d-alpha-tocopherol in the form of tocofersolan.
2 ml brizga ima označbe od 0,1 do 2 ml v korakih po 0,1 ml. Ena označba na 2 ml brizgi za peroralno uporabo ustreza 5 mg d-alfa-tokoferola v obliki tokofersolana.
Vedrop contains 0.18 mmoles (4.1 mg) sodium per ml.
Zdravilo Vedrop vsebuje 0,18 mmolov (4,1 mg) natrija na ml. Posvetujte se z zdravnikom, če ste na dieti z nadzorovanim vnosom natrija.
Slightly viscous, pale yellow solution.
peroralna raztopina Rahlo gosta, svetlorumena raztopina.
Recordati Rare Diseases Immeuble “le Wilson” 70 avenue du Général de Gaulle 92800 Puteaux
Recordati Rare Diseases Immeuble “Le Wilson” 70, avenue du Général de Gaulle F-92800 Puteaux
The 1 ml oral syringe is graduated from 0.05 to 1 ml in steps of 0.05 ml.
1 ml brizga ima označbe od 0,05 do 1 ml v korakih po 0,05 ml. Ena označba na 1 ml brizgi za peroralno uporabo ustreza 2,5 mg d-alfa-tokoferola v obliki tokofersolana.
ANNEX III LABELLING AND PACKAGE LEAFLET
OZNAČEVANJE IN NAVODILA ZA UPORABO
This summary was last updated in 07-2010.
Povzetek je bil nazadnje posodobljen 07-2010.
It contains the following
Vsebuje naslednje zdravilne
The choice of which vaccine to use depends on official recommendations.
Izbira, katero cepivo uporabiti, je odvisna od uradnih priporočil.
This helps to protect against the diseases that these bacteria and viruses cause.
To pomaga pri zaščiti pred boleznimi, ki jih te bakterije in virusi
• polioviruses (types 1, 2 and 3) that have been inactivated (killed) so that they do not cause any
• poliovirusov (tipov 1, 2 in 3), ki so bili inaktivirani (uničeni), tako da ne povzročijo bolezni.
This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
To pomeni, da so zdravilne učinkovine vezane na aluminijeve spojine, kar spodbudi boljši odziv.
The site of injection should be alternated for subsequent injections.
Mesto injiciranja je treba pri naslednjih injekcijah zamenjati.
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Penta to GlaxoSmithKline Biologicals s.a. on 23 October 2000.
Evropska komisija je dovoljenje za promet s cepivom Infanrix Penta, veljavno po vsej Evropski uniji, odobrila družbi GlaxoSmithKline Biologicals s.a. dne 23. oktobra 2000.
Their breathing should be monitored for up to three
Njihovo dihanje je treba
For more information about treatment with Infanrix Penta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Infanrix Penta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
After one month, between 86 and 100% of the infants had developed protective levels of antibodies against all of the active substances in Infanrix Penta.
Po enem mesecu je od 86 % do 100 % otrok razvilo zaščitne ravni protiteles proti vsem učinkovinam v cepivu Infantrix Penta.
This document is a summary of the European public assessment report (EPAR) for Infanrix Penta.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Infanrix Penta.
The studies showed that a first course of vaccination with Infanrix Penta led to the development of protective levels of antibodies.
Študije so pokazale, da je prvo cepljenje s cepivom Infantrix Penta pripeljalo do razvoja zaščitnih ravni protiteles.
The main measure of effectiveness was the production of antibodies against the active substances after vaccination.
Glavno merilo učinkovitosti je bila tvorba protiteles proti zdravilnim učinkovinam po cepljenju.
The surface antigens of the hepatitis B virus are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Površinski antigeni virusa hepatitisa B se izdelujejo z metodo, imenovano „tehnologija rekombinantne DNK“: proizvajajo jih kvasovke, ki so prejele gen (DNK), s katerim lahko
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Ko otrok prejme cepivo, imunski sistem prepozna dele bakterij in virusov kot „tujke“ in proti njim razvije protitelesa.
The recommended vaccination schedule for Infanrix Penta is two or three doses, given at least one month apart, usually within the first six months of life.
Priporočena shema cepljenja s cepivom Infanrix Penta sta dva ali trije odmerki, ki se dajo v presledku vsaj enega meseca, običajno v prvih šestih mesecih življenja.
The marketing authorisation is valid for
Dovoljenje za promet z
The studies involved over 10,000 infants, about three quarters of whom received Infanrix Penta, given according to various time schedules.
V študije je bilo vključenih več kot 10 000 otrok, od katerih so približno tri četrtine prejele cepivo Infanrix Penta, dano v različnih časovnih razporedih.
• toxoids and other proteins purified from B. pertussis;
• toksoidov in drugih beljakovin, prečiščenih iz B. pertussis,
• surface antigen (proteins from the surface) of the hepatitis B virus;
• površinskega antigena (beljakovin s površine) virusa hepatitisa B,
A booster dose of Infanrix Penta or a similar vaccine must be given at least six months after the last dose of the initial course.
Obnovitveni odmerek cepiva Infanrix Penta ali podobnega cepiva je treba dati najmanj šest mesecev po zadnjem odmerku začetnega cepljenja.
Infanrix Penta has been studied in 16 studies looking at the first course of vaccination.
Cepivo Infanrix Penta so raziskovali v 16 študijah, v katerih so proučevali prvi cikel cepljenja.
The most common side effects with Infanrix Penta (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
Najpogostejši neželeni učinki cepiva Infanrix Penta (opaženi pri več kot 1 odmerku cepiva od 10) so izguba teka, povišana telesna temperatura na 38ºC ali več, lokalna oteklina, bolečina in rdečina na mestu injiciranja, utrujenost, neobičajen jok, razdražljivost in nemir.
Other information about Infanrix Penta:
Druge informacije o zdravilu Infanrix Penta:
• toxoids from the bacteria that cause diphtheria and tetanus;
• toksoidov iz bakterij, ki povzročajo davico in tetanus,
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 Infanrix Penta.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Infanrix Penta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Infanrix Penta is a vaccine.
Infanrix Penta je cepivo.
Infanrix Penta is a vaccine, which is available as a suspension for injection.
Infanrix Penta je cepivo, ki je na voljo kot suspenzija za injiciranje.
• toxoids (chemically weakened toxins) from diphtheria and tetanus; • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
• toksoide (kemično oslabljene toksine) iz bakterij, ki povzročajo davico in tetanus; • dele bakterije Bordetella pertussis (B. pertussis, bakterije, ki povzroča oslovski kašelj);
Infanrix Penta is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis and polioviruses are available in other vaccines.
Cepivo Infanrix Penta je kombinacija sestavin, ki so v Evropski uniji (EU) na voljo v drugih cepivih: komponente davice, tetanusa, oslovskega kašlja in hepatitisa B so bili na voljo v cepivu Infanrix HepB od leta 1997 do 2005, komponente davice, tetanusa, oslovskega kašlja in poliovirusi pa so na voljo v
Infanrix Penta has also been studied in nine studies of booster vaccination involving over 4,000 infants, 714 of whom received Infanrix Penta as a booster.
Cepivo Infanrix Penta so proučevali tudi v devetih študijah obnovitvenega cepljenja, v katere je bilo vključenih okoli 4 000 dojenčkov, od katerih jih je 714 cepivo Infanrix Penta prejelo kot obnovitveno cepljenje.
The CHMP decided that Infanrix Penta's benefits are greater than its risks and recommended that it be
CHMP je zaključil, da so koristi zdravila Infanrix Penta večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
After booster vaccination, there was an increase in the number of infants with protective levels of antibodies against the active substances.
Po obnovitvenem cepljenju se je povečalo število otrok z zaščitnimi ravnmi protiteles proti zdravilnim učinkovinam.
What benefit has Infanrix Penta shown during the studies?
Kakšne koristi je zdravilo Infanrix Penta izkazalo med študijami?
Infanrix Penta can be given to infants who received a hepatitis B vaccine at birth.
Cepivo Infanrix Penta se lahko da dojenčkom, ki so bili ob rojstvu cepljeni proti hepatitisu B.
For the full list of all side effects reported with Infanrix Penta, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Infanrix Penta, glejte navodilo za uporabo.
Infanrix Penta is given by deep injection into a muscle.
Cepivo Infanrix Penta se daje z globoko injekcijo v mišico.
Infanrix Penta must not be used in infants who have had encephalopathy (brain disease) of unknown cause within seven days of receiving a vaccine containing pertussis components in the past.
Prav tako se ne sme uporabljati pri otrocih, ki so v preteklosti imeli encefalopatijo (obolenje možganov) neznanega vzroka v sedmih dneh po prejemu cepiva, ki je vsebovalo komponente oslovskega kašlja.
diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Cepivo (adsorbirano) proti davici (D), tetanusu (T), oslovskemu kašlju (acelularno, komponentno)(PA), hepatitisu B (rDNA)(HBV), otroški
It must not be used in infants who have had an allergic reaction after receiving a vaccine containing diphtheria, tetanus, pertussis, hepatitis B or polio in the past.
Ne sme se uporabljati pri otrocih, ki so imeli alergijsko reakcijo na prejšnje cepivo proti davici, tetanusu, oslovskemu kašlju, hepatitisu B ali otroški ohromelosti.
What is the risk associated with Infanrix Penta?
Kakšna tveganja so povezana z zdravilom Infanrix Penta?
As for all vaccines, if Infanrix Penta is used in babies born very prematurely, there is a risk of them experiencing apnoea (brief pauses in breathing).
Tako kot pri vseh cepivih obstaja tudi pri cepivu Infanrix Penta tveganje za razvoj apneje (kratkih premorov pri dihanju), če se daje mnogo prezgodaj rojenim dojenčkom.
Infanrix Penta should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics).
Zdravila Infanrix Penta ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli od zdravilnih učinkovin, katero koli od drugih sestavin zdravila ali polimiksin (antibiotik).
Why has Infanrix Penta been approved?
Zakaj je bilo zdravilo Infanrix Penta odobreno?
Infanrix Penta is used to protect infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B and poliomyelitis (polio).
Zdravilo Infanrix Penta se uporablja za cepljenje otrok, mlajših od treh let, proti davici, tetanusu, oslovskemu kašlju, hepatitisu B in otroški ohromelosti (polio).
Infanrix Penta contains small amounts of:
Cepivo Infanrix Penta vsebuje majhne količine:
The full EPAR for Infanrix Penta can be found here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za cepivo Infanrix Penta je na voljo tukaj.
How is Infanrix Penta used?
Kako se zdravilo Infanrix Penta uporablja?
It was to be available as 300 mg tablets.
Na voljo naj bi bilo v obliki 300 mg tablet.
EMA/261739/2015 EMEA/H/C/002830
21. maj 2015 EMA/386096/2015 EMEA/H/C/002830
The study looked at improvements in blood sugar levels and blood pressure following 24 weeks of Corluxin treatment.
V študiji so proučevali izboljšanja ravni sladkorja v krvi in krvnega tlaka po 24 tednih zdravljenja z zdravilom Corluxin.
Corluxin was not compared with any other medicine.
Zdravila Corluxin niso primerjali z nobenim drugim zdravilom.
In its letter notifying the Agency of the withdrawal of application, the company stated that the withdrawal was due to strategic business reasons.
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da je vlogo umaknila zaradi strateških poslovnih razlogov.
The applicant submitted data from a main study involving 50 patients with Cushing's syndrome who had diabetes and/or high blood pressure, two common features of the condition.
Predlagatelj je predložil podatke iz glavne študije, v kateri je sodelovalo 50 bolnikov s Cushingovim sindromom, ki so imeli sladkorno bolezen in/ali visok krvni tlak, tj. dve pogosti značilnosti tega stanja.
The CHMP had concerns related to the manufacture of the medicine, including the control of impurities and the testing of the finished product.
CHMP je imel pomisleke glede proizvodnje zdravila, vključno z nadzorom nečistot in testiranjem končnega izdelka.
The CHMP also had concerns about the main study, citing, among other things, the lack of a comparator medicine.
CHMP je imel tudi pomisleke glede glavne študije, citiranja in med drugim tudi pomanjkanja primerjalnega zdravila.
The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Vlogo so umaknili po tem, ko je CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in pripravil seznam vprašanj.
On the whole, the evidence for effectiveness in the indication applied for was limited and there were some safety concerns with the medicine, including side effects caused by the reduced activity of circulating cortisol, fluid and mineral disturbances (particularly reduced potassium levels in blood and increased blood pressure in some patients) and thickening of the womb in some female patients.
Na splošno je bil dokaz učinkovitosti pri indikaciji, navedeni v vlogi, omejen, bilo pa je tudi nekaj varnostnih zadržkov v zvezi z zdravilom, vključno z neželenimi učinki zaradi zmanjšanega delovanja kortizola v obtoku, motenj tekočin in mineralov (še posebej zmanjšane ravni kalija v krvi in povišanega krvnega tlaka pri nekaterih bolnikih) in odebelitve maternice pri nekaterih bolnicah.
On 23 March 2015, FGK Representative Service GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Corluxin, intended for the treatment of Cushing's syndrome.
Družba FGK Representative Service GmbH je dne 23. marca 2015 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Corluxin, namenjenim zdravljenju Cushingovega sindroma.
Patients with Cushing's syndrome can have ‘central' weight gain (affecting the face and torso but not the limbs), growth of fat above the collar bone and the back of the neck, a roundish face, easy bruising, excessive growth of coarse hair on the face, weakening of the muscles and bones, depression, diabetes and high blood pressure.
Pri bolnikih s Cushingovim sindromom se lahko pojavijo „centralno“ pridobivanje telesne mase (na obrazu in trupu, vendar ne na okončinah), nakopičenje maščobe nad ključnico in zadnjo stranjo vratu, okrogel obraz, nagnjenost k modricam, prekomerna rast grobih dlak na obrazu, slabenje mišic in kosti, depresija, sladkorna bolezen in visok krvni tlak.
By blocking these receptors, mifepristone is expected to reduce the effects of the excess cortisol circulating in the body, thereby alleviating the symptoms of the disease.
Z zaviranjem teh receptorjev naj bi mifepriston zmanjšal učinke povečanih ravni kortizola v telesu in tako ublažil simptome bolezni.
Withdrawal of the marketing authorisation application for Corluxin (mifepristone)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Corluxin (mifepriston)
Corluxin is a medicine containing the active substance mifepristone.
Corluxin je zdravilo, ki vsebuje zdravilno učinkovino mifepriston.
The active substance in Corluxin, mifepristone, is known to block receptors for cortisol known as glucocorticoid (GR-II) receptors.
Za zdravilno učinkovino v zdravilu Corluxin, mifepriston, je znano, da zavira receptorje za kortizol, imenovane glukokortikoidni receptorji (GR-II).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Corluxin in the proposed indication did not outweigh its risks.
Zato je CHMP v času umika vloge menil, da koristi zdravila Corluxin pri predlagani indikaciji ne odtehtajo z njim povezanih tveganj.
The company informed the CHMP that, at the time of the withdrawal, there were no ongoing clinical trials or compassionate use programmes for Corluxin.
Družba je obvestila CHMP, da v času umika vloge niso potekala nobena klinična preskušanja ali programi sočutne uporabe zdravila Corluxin.
Withdrawal of the marketing authorisation application for Corluxin (mifepristone) EMA/261739/2015
Umik vloge za pridobitev dovoljenja za promet z zdravilom Corluxin (mifepriston) EMA/386096/2015
What is Corluxin?
Kaj je zdravilo Corluxin?
Corluxin was to be used to treat Cushing's syndrome in patients who cannot have surgery or for whom surgery has failed.
Zdravilo Corluxin naj bi se uporabljalo za zdravljenje Cushingovega sindroma pri bolnikih, pri katerih kirurški poseg ni mogoč ali ni bil uspešen.
At the time of the withdrawal, the CHMP was of the provisional opinion that Corluxin could not be approved for use in the broad indication the company applied for, which was the “treatment of adult patients with endogenous Cushing's syndrome for whom surgery is not an option or for whom surgery has failed.”
V času umika je CHMP začasno menil, da zdravila Corluxin ni mogoče odobriti za uporabo pri široki indikaciji, za katero je zaprosila družba, tj. za zdravljenje odraslih bolnikov z endogenim Cushingovim sindromom, pri katerih kirurški poseg ni mogoč ali ni bil uspešen.
What was Corluxin expected to be used for?
Za kaj naj bi se zdravilo Corluxin uporabljalo?
How is Corluxin expected to work?
Kako naj bi zdravilo Corluxin delovalo?
Cushing's syndrome is a disease characterised by an excess production of the hormone cortisol by the adrenal glands, two glands situated above the kidneys.
Cushingov sindrom je bolezen, pri kateri nadledvični žlezi, tj. žlezi, ki se nahajata nad ledvicami, tvorita čezmerne količine hormona kortizola.
Annex IV
Dodatek IV
Communication Plan
Načrt sporočanja
The harmonised date for release of the letter is of 15 working days following the European Commission decision.
Usklajeni datum za objavo sporočila je 15 delovnih dni po odločitvi Evropske komisije.
The MAHs should inform healthcare professionals on the outcome of this review on nimesulide via a “Direct Healthcare Professional Communication” (DHPC) as agreed by the CHMP.
Imetniki dovoljenj za promet z zdravilom morajo zdravstvene strokovnjake obvestiti o izidu pregleda nimesulida z „neposrednim obvestilom za zdravstvene delavce“, kot je bilo dogovorjeno z CHMP.
CONDITIONS OF THE MARKETING AUTHORISATIONS National Competent Authorities, coordinated by the Reference Member State where applicable, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, kjer je potrebno, zagotovijo, da imetniki dovoljenj za promet z zdravilom izpolnijo naslednje pogoje:
Condition of the marketing authorisations
Pogoj dovoljenja za promet z zdravilom
EMEA/457286/2008-EN
EMEA/457286/2008-SL
London, August 2008 EMEA/457286/2008
London, avgust 2008 EMEA/457286/2008
The CVMP Opinion was adopted on 12 December 2007 and the subsequent Commission Decision on 11 March 2008.
Mnenje Odbora za zdravila za uporabo v veterinarski medicini je bilo sprejeto dne 12. decembra 2007, Odločba Komisije pa dne 11. marca 2008.
o The Periodic Safety Update Reports for at least the last 3 years.
o Periodičnih poročilao varnosti zdravila najmanj za zadnja tri leta.