natgillin/translations-raw huggingface dataset:
However, the MAH confirmed that a re-test was carried out according to the finished product specifications agreed during the MRP and the vaccine batches were found to conform to them.
Vendar je imetnik dovoljenja za promet z zdravilom potrdil, da je izvedel ponovno testiranje skladno s specifikacijami za končno zdravilo, ki so jih odobrili med postopkom z medsebojnim priznavanjem, in da je ugotovil, da so bile serije cepiva skladne z njimi.
The vaccine contains five, formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae.
Cepivo vsebuje pet s formaldehidom inaktiviranih sevov bacila Actinobacillus pleuropneumoniae.
The MAH presented the results of all the laboratory studies to support the efficacy claims.
Imetnik dovoljenja za promet z zdravilom je kot podporo trditvam o učinkovitosti predstavil rezultate vseh laboratorijskih študij.
Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae.
Cepljeni prašiči razvijejo aktivno imunost proti boleznim povzročenim s serotipi 1 ali 2 Actinobacillus pleuropneumoniae.
Onset of immunity is 21 days following second vaccination.
Imunost se razvije 21 dni po drugem cepljenju.
Grounds for the granting of the marketing authorisations for Coglapix suspension for injection for pigs
Podlaga za izdajo dovoljenja za promet z zdravilom Coglapix suspenzija za injiciranje za prašiče
Onset of immunity: 21 days following second vaccination Duration of immunity: 16 weeks following second vaccination
Trajanje imunosti: 16 tednov po drugem cepljenju
The CVMP agreed that although the incidence of typical clinical signs and lung lesions were not significantly lower for vaccinates, when compared with controls, in all laboratory efficacy studies, the overall results of the efficacy of the vaccine were supportive for reduction of lung lesions and clinical signs.
Odbor CVMP se je strinjal, da so skupni rezultati vseh laboratorijskih študijah za učinkovitost cepiva podprli zmanjšanje pljučnih lezij in kliničnih znakov, čeprav pojavnost značilnih kliničnih znakov in pljučnih lezij ni bila pomembno manjša pri cepivih v primerjavi s kontrolnimi skupinami.
The concern related to the overall efficacy of the vaccine have been assessed and it is concluded that Coglapix is expected to be efficacious in immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Ocenili so pomislek glede splošne učinkovitosti cepiva in sklenili, da je pričakovati, da bo zdravilo Coglapix učinkovito pri imunizaciji prašičev, kar bo pomagalo nadzorovati plevropnevmonijo, ki jo povzročata serotipa 1 in 2 A. pleuropneumoniae, saj omogoča zmanjšanje kliničnih znakov in pljučnih lezij, povezanih z boleznijo.
Coglapix is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Zdravilo Coglapix je namenjeno aktivni imunizaciji prašičev proti plevropnevmoniji, ki jo povzročata serotipa 1 in 2 A. pleuropneumoniae.
For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Za aktivno imunizacijo prašičev kot pomoč pri nadzoru pleuropnevmonije povzročene z Actinobacillus pleuropneumoniae serotip 1 in 2, z zmanjšanjem kliničnih znakov in poškodb pljuč, povezanih z boleznijo.
Coglapix is intended for active immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, and reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory studies.
Zdravilo Coglapix je namenjeno aktivni imunizaciji prašičev kot pomoč pri nadzorovanju plevropnevmonije, ki jo povzročajo serotipi 1 in 2 A. pleuropneumoniae, zmanjšanje kliničnih znakov ter pljučnih lezij, povezanih s to boleznijo, pa so dokazali v laboratorijskih študijah.
The vaccine is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, in order to reduce the clinical signs and lung lesions associated with the disease.
Cepivo je namenjeno aktivni imunizaciji prašičev proti plevropnevmoniji, ki jo povzročajo serotipi 1 in 2 A. pleuropneumoniae, s čimer se zmanjšajo klinični znaki in pljučne lezije, povezani s to boleznijo.
Iceland Ceva Santé Animale 10, av. de La
Islandija Ceva Santé Animale 10, av. de La
Lithuania Ceva Santé Animale 10, av. de La
Hrvaška Ceva Santé Animale 10, av. de La
Finland Ceva Santé Animale 10, av. de La
Estonija Ceva Santé Animale 10, av. de La
Libourne
Ciper
The full EPAR for Pemetrexed Hospira UK Limited can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Pemetreksed Hospira UK Limited je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Ker je zdravilo Pemetreksed Hospira UK Limited generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira UK Limited has been shown to be comparable to Alimta.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetreksed Hospira UK Limited primerljivo z zdravilom Alimta.
In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Pemetreksed se v telesu pretvori v aktivno obliko, ki zavira delovanje encimov, ki sodelujejo pri tvorbi „nukleotidov“ (gradnikov DNK in RNK, genskega materiala celic).
This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK Limited.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetreksed Hospira UK Limited.
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Hospira UK Limited.
Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Alimta, zato jih ni treba ponoviti za zdravilo Pemetreksed Hospira UK Limited.
The Committee recommended that Pemetrexed Hospira UK Limited be approved for use in the EU.
Priporočil je, da se zdravilo Pemetreksed Hospira UK Limited odobri za uporabo v EU.
Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
Pemetreksed Hospira UK Limited je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira UK Limited?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetreksed Hospira UK Limited?
As for every medicine, the company provided studies on the quality of Pemetrexed Hospira UK Limited.
Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Pemetreksed Hospira UK Limited.
This means that Pemetrexed Hospira UK Limited contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilo Alimta.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Hospira UK Limited have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Pemetreksed Hospira UK Limited upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Hospira UK Limited is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Izvedba študij biološke enakovrednosti, s katerimi se proučuje, ali se zdravilo Pemetreksed Hospira UK Limited absorbira podobno kot referenčno zdravilo in tako ustvari enake ravni zdravilne učinkovine v krvi, ni bila potrebna.
For more information about treatment with Pemetrexed Hospira UK Limited, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Pemetreksed Hospira UK Limited preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Pri bolnikih, ki so prejemali kemoterapijo na osnovi platine, se lahko uporablja tudi za vzdrževalno zdravljenje.
For practical information about using Pemetrexed Hospira UK Limited, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Pemetreksed Hospira UK Limited naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
When Pemetrexed Hospira UK Limited is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Kadar se zdravilo Pemetreksed Hospira UK Limited daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem bolniku dati tudi „antiemetično“ zdravilo (za preprečevanje bruhanja) in tekočino (za preprečevanje dehidracije).
What is Pemetrexed Hospira UK Limited and what is it used for?
Kaj je zdravilo Pemetreksed Hospira UK Limited in za kaj se uporablja?
To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira UK Limited.
Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Pemetreksed Hospira UK Limited jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
This is because Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Razlog za to je dejstvo, da se zdravilo Pemetreksed Hospira UK Limited daje z infundiranjem v veno, zaradi česar zdravilna učinkovina vstopi neposredno v krvni obtok.
What are the benefits and risks of Pemetrexed Hospira UK Limited?
Kakšne so koristi in tveganja, povezani z zdravilom Pemetreksed Hospira UK Limited?
The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Zdravilna učinkovina v zdravilu Pemetreksed Hospira UK Limited, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
Other information about Pemetrexed Hospira UK Limited
Druge informacije o zdravilu Pemetreksed Hospira UK Limited
Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion (drip) into a vein.
Zdravilo Pemetreksed Hospira UK Limited je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
Pemetrexed Hospira UK Limited pemetrexed
Pemetreksed Hospira UK Limited pemetreksed
Why is Pemetrexed Hospira UK Limited approved?
Zakaj je bilo zdravilo Pemetreksed Hospira UK Limited odobreno?
Pemetrexed Hospira UK Limited contains the active substance pemetrexed.
Zdravilo Pemetreksed Hospira UK Limited vsebuje zdravilno učinkovino pemetreksed.
How has Pemetrexed Hospira UK Limited been studied?
Kako je bilo Pemetreksed Hospira UK Limited raziskano?
Pharmaceutical Form Route of Administration Packaging
Farmacevtska oblika pot uporabe ovojnina
Invented name
Številka EU Izmišljeno ime jakost
It is given over 1 hour, every 8 hours.
Infundira se eno uro vsakih osem ur.
Further information on Zerbaxa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Nadaljnje informacije za zdravilo Zerbaxa so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zerbaxa.
The dose and duration of treatment depends on the infection being treated and how the infection responds to the medicine.
Odmerek in trajanje zdravljenja sta odvisna od zdravljene okužbe in odziva okužbe na zdravilo.
The second study involved 993 patients with complicated intra-abdominal infections.
V drugi študiji je sodelovalo 993 bolnikov z zapletenimi intraabdominalnimi okužbami.
Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
V zvezi z varnostjo je menila, da so neželeni učinki značilni in pričakovani za to vrsto antibiotika.
The European Medicines Agency decided that Zerbaxa's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Zerbaxa večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Zerbaxa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zerbaxa?
Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
Za zdravilo Zerbaxa je bilo 18. septembra 2015 izdano dovoljenje za promet, veljavno po vsej EU.
As for all medicines, data on the use of Zerbaxa are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zerbaxa stalno spremljajo.
The third study involved 726 patients who were using a ventilator and who had either hospitalacquired pneumonia or ventilator-associated pneumonia.
V tretjo študijo je bilo vključenih 726 bolnikov, ki so uporabljali ventilator, in imeli bodisi bolnišnično pljučnico ali pljučnico, povezano z uporabo ventilatorja.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zerbaxa have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zerbaxa upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Other information about Zerbaxa
Druge informacije o zdravilu Zerbaxa
It works by interfering with the production of molecules that bacteria need to build their protective cell walls.
Deluje tako, da ovira tvorbo molekul, ki jih bakterije potrebujejo za gradnjo svojih zaščitnih celičnih sten.
• hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
• bolnišnično pljučnico (okužbo pljuč, ki se zgodi v bolnišnici), vključno s pljučnico, ki lahko prizadene bolnike, ki uporabljajo ventilator, aparat, ki jim pomaga pri dihanju.
The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea (feeling sick), headache, constipation, diarrhoea and fever.
Najpogostejši neželeni učinki zdravila Zerbaxa (ki se lahko pojavijo pri največ 1 bolniku od 10) so navzeja (siljenje na bruhanje), glavobol, zaprtje, driska in povišana telesna temperatura.
For more information about using Zerbaxa, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Zerbaxa glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Zerbaxa, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Zerbaxa authorised in the EU?
Zakaj je bilo zdravilo Zerbaxa odobreno v EU?
One study involved 1,083 patients who mostly had kidney infection or in some cases a complicated urinary-tract infection.
V eno študijo je bilo vključenih 1 083 bolnikov, ki so večinoma imeli okužbo ledvic, v nekaterih primerih pa je šlo tudi za zapleteno okužbo sečil.
Ceftolozane is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called betalactams.
Ceftolozan je vrsta antibiotika, imenovanega cefalosporin, ki spada v obširnejšo skupino, imenovano „betalaktamski antibiotiki“.
Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Zdravilo Zerbaxa se ne sme uporabljati pri osebah, ki so preobčutljive za (alergične na) zdravilo Zerbaxa ali katero koli drugo sestavino zdravila, ter pri tistih, ki so preobčutljivi za druge cefalosporinske antibiotike ali ki so kdaj imeli hudo alergijsko reakcijo na drug betalaktamski antibiotik.
• serious kidney infection (acute pyelonephritis);
• hudo okužbo ledvic (akutnim pielonefritisom);
The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
Agencija je menila, da je bilo dokazano, da je zdravilo Zerbaxa učinkovito pri zdravljenju okužb pri proučevanih bolnikih, vendar je pri tem izpostavila, da je v študijah sodelovalo le omejeno število bolnikov z zapletenimi okužbami sečil.
Zerbaxa is an antibiotic used to treat adults with:
Zdravilo Zerbaxa je antibiotik, ki se uporablja za zdravljenje odraslih bolnikov z:
An overview of Zerbaxa and why it is authorised in the EU
Pregled zdravila Zerbaxa in zakaj je odobreno v EU
What benefits of Zerbaxa have been shown in studies?
Kakšne koristi zdravila Zerbaxa so se pokazale v študijah?
Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
Obe zdravili sta ozdravili približno 94 % bolnikov (353 od 375, ki so prejemali zdravilo Zerbaxa, in 375 od 399, ki so prejemali meropenem).
Zerbaxa was compared with another antibiotic, meropenem.
Zdravilo Zerbaxa so primerjali z drugim antibiotikom, imenovanim meropenem.
The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways.
Učinkovini zdravila Zerbaxa , ceftolozan in tazobaktam, delujeta na različna načina.
It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Pokazala je, da je zdravilo Zerbaxa vsaj tako učinkovito kot meropenem: okužba je bila ozdravljena pri 54 % (197 od 362) bolnikov po 7 do 14 dneh zdravljenja z zdravilom Zerbaxa, v primerjavi s 53 % (194 od 362) bolnikov, zdravljenih z meropenemom.
The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance.
Prav tako je izpostavila, da tazobaktam ne deluje proti določenim vrstam betalaktamaz, kar lahko povzroči težave z odpornostjo.
This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
S tem povzroči šibkost bakterijskih celičnih sten, ki zato lažje propadejo, zaradi česar bakterije sčasoma odmrejo.
Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
Zdravilo Zerbaxa je uspešno ozdravilo okužbo pri približno 85 % (288 od 340) bolnikov, ki so ga prejemali, v primerjavi s 75 % (266 od 353) bolnikov, ki so prejemali drug antibiotik, imenovan levofloksacin.
What are the risks associated with Zerbaxa?
Kakšna tveganja so povezana z zdravilom Zerbaxa?
What is Zerbaxa and what is it used for?
Kaj je zdravilo Zerbaxa in za kaj se uporablja?
Zerbaxa is available for infusion (drip) into a vein and can only be obtained with a prescription.
Zdravilo Zerbaxa je na voljo kot (kapalna) infuzija v veno in se predpisuje in izdaja le na recept.
• complicated infections of the urinary tract (structures that carry urine, such as the bladder);
• zapletenimi okužbami sečil (struktur, po katerih se prenaša urin, na primer mehurja);
By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to ceftolozone.
Z zaviranjem delovanja teh encimov tazobaktam omogoča ceftolozanu, da učinkovito deluje proti bakterijam, ki bi sicer bile nanj odporne.
Zerbaxa has been shown to be at least as effective as other antibiotics in curing infections in three main studies.
Tri glavne študije so pokazale, da je zdravilo Zerbaxa vsaj tako učinkovito pri zdravljenju okužb kot drugi antibiotiki.
• complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
• zapletenimi (težko ozdravljivimi) okužbami tkiv in organov v trebušnem predelu
For the full list of side effects of Zerbaxa, see the package leaflet.
Za celoten seznam neželenih učinkov zdravila Zerbaxa glejte navodilo za uporabo.
These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic's action.
Ti encimi bakterijam omogočajo, da razgrajujejo betalaktamske antibiotike, kot je ceftolozan, in posledično postanejo odporne proti njihovemu delovanju.
How is Zerbaxa used?
Kako se zdravilo Zerbaxa uporablja?
How does Zerbaxa work?
Kako zdravilo Zerbaxa deluje?
Zerbaxa contains the active substances ceftolozane and tazobactam.
Vsebuje učinkovini ceftolozan in tazobaktam.
The European Commission issued a decision on 10 January 2010.
Evropska komisija je odločbo izdala dne 10. januarja 2010.
This variation was to be recognised in Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain and Sweden (the concerned Member States).
Ta sprememba bi se morala priznati v zadevnih državah članicah: Avstrija, Belgija, Danska, Finska, Francija, Grčija, Irska, Italija, Luksemburg, Nemčija, Nizozemska, Portugalska, Španija in Švedska.
Ref.: EMEA/CHMP/683039/2009 EMEA/H/A-6(12)/1203
: EMEA/CHMP/683039/2009 EMEA/H/A-6(12)/1203
Dr Ian Hudson (United Kingdom)
Dr. Ian Hudson (Združeno kraljestvo)
Why was Extraneal reviewed?
Zakaj je bilo zdravilo Extraneal pregledano?
Dr Barbara van Zwieten Boot (Netherlands)
Dr. Barbara van Zwieten Boot (Nizozemska)
23 July 2009
23. julija 2009
The review was carried out under an ‘Article 6(12)' referral1.
Pregled je bil izveden v skladu z napotitvenim postopkom1 po členu 6(12).
Extraneal is authorised in the European Union under a mutual recognition procedure on the basis of the initial authorisation granted by the United Kingdom in 1997.
Zdravilo Extraneal je v Evropski uniji odobreno s postopkom medsebojnega priznavanja na osnovi prvotne odobritve v Združenem kraljestvu leta 1997.
What is Extraneal?
Kaj je zdravilo Extraneal?
Because these Member States were not able to reach an agreement, the Dutch medicines regulatory agency referred the matter to the CHMP for arbitration on 9 July 2009.
Ker omenjene države članice niso dosegle soglasja, je nizozemski regulatorni organ dne 9. julija 2009 zadevo napotila na CHMP v arbitražo.