natgillin/translations-raw huggingface dataset:
Patients should not use more than one capsule in a day. 
Bolnik ne sme uporabiti več kot ene kapsule na dan.
The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment. 
Poudarila je tudi, da lahko dejstvo, da se zdravilo uporablja enkrat na dan, pripomore k redni uporabi zdravila.
Further information on Seebri Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije za zdravilo Seebri Breezhaler so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second). 
Glavno merilo učinkovitosti v obeh študijah je bilo izboljšanje forsiranega ekspiracijskega volumna (FEV1 - največje količine zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih.
Therefore, the Agency decided that Seebri Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU. 
Zato je agencija zaključila, da so koristi zdravila Seebri Breezhaler večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
The most common side effects with Seebri Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting). 
Najpogostejši neželeni učinki zdravila Seebri Breezhaler (opaženi pri več kot 1 bolniku od 100) so suha usta, nazofaringitis (vnetje nosu in žrela), nespečnost (težave s spanjem), bolečine v mišicah in kosteh ter gastroenteritis (driska in bruhanje).
To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule. 
Odmerek se vzame tako, da bolnik namesti kapsulo v inhalator in skozi usta vdihne prašek iz kapsule.
After 12 weeks of treatment, Seebri Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study. 
Po 12 tednih zdravljenja je bilo povečanje vrednosti FEV1 pri uporabi zdravila Seebri Breezhaler v prvi študiji za 97 ml večje kot pri uporabi placeba, v drugi pa za 108 ml.
This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs. 
To pomeni, da razširi dihalne poti tako, da zavre muskarinske (ciljne) receptorje v celicah pljučnih mišic.
The European Medicines Agency noted that Seebri Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD. 
Evropska agencija za zdravila je menila, da ima zdravilo Seebri Breezhaler zmerno vendar pomembno korist za bolnike v smislu izboljšanja pljučne funkcije in da izboljšuje simptome KOPD.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Seebri Breezhaler 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 Seebri Breezhaler upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Seebri Breezhaler are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Seebri Breezhaler, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. 
KOPB je bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali zamašeni, zaradi česar je dihanje oteženo.
Seebri Breezhaler capsules, which contain a powder for inhalation, are only used with the Seebri Breezhaler inhaler and must not be swallowed. 
Kapsule zdravila Seebri Breezhaler, ki vsebujejo prašek za inhaliranje, je treba uporabljati izključno z inhalatorjem za zdravilo Seebri Breezhaler in se jih ne sme pogoltniti.
Seebri Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD. 
Zdravilo Seebri Breezhaler je bilo učinkovitejše od placeba (zdravila brez zdravilne učinkovine) pri lajšanju simptomov KOPD v dveh glavnih študijah, v katerih je sodelovalo skupno 1 888 bolnikov s
Seebri Breezhaler is used for maintenance (regular) treatment. 
Zdravilo Seebri Breezhaler se uporablja za vzdrževalno (redno) zdravljenje.
As for all medicines, data on the use of Seebri Breezhaler are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Seebri Breezhaler stalno spremljajo.
For more information about treatment with Seebri Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Seebri Breezhaler preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
An overview of Seebri Breezhaler and why it is authorised in the EU 
Pregled zdravila Seebri Breezhaler in zakaj je odobreno v EU
Seebri Breezhaler received a marketing authorisation valid throughout the EU for Seebri Breezhaler on 28 September 2012. 
Za zdravilo Seebri Breezhaler je bilo 28. septembra 2012 izdano dovoljenje za promet, veljavno po vsej Evropski uniji.
In addition, there were no major safety concerns with Seebri Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines. 
Poleg tega ni ugotovila nobenih zadržkov glede varnosti zdravila Seebri Breezhaler, njegovi neželeni učinki pa so podobni tistim, ki so značilni za ostale antagoniste muskarinskih receptorjev.
What measures are being taken to ensure the safe use of Seebri Breezhaler? 
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila Seebri Breezhaler?
Why is Seebri Breezhaler authorised in the EU? 
Zakaj je bilo zdravilo Seebri Breezhaler odobreno v EU?
Other information about Seebri Breezhaler 
Druge informacije o zdravilu Seebri Breezhaler
The active substance in Seebri Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist. 
Zdravilna učinkovina v zdravilu Seebri Breezhaler, glikopironijev bromid, je antagonist muskarinskih receptorjev.
Seebri Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults. 
Zdravilo Seebri Breezhaler se uporablja za lajšanje simptomov pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
What is Seebri Breezhaler and what is it used for? 
Kaj je zdravilo Seebri Breezhaler in za kaj se uporablja?
For more information about using Seebri Breezhaler, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Seebri Breezhaler glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
What benefits of Seebri Breezhaler have been shown in studies? 
Kakšne koristi je zdravilo Seebri Breezhaler izkazalo v študijah?
For the full list of all side effects and restrictions with Seebri Breezhaler, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Seebri Breezhaler glejte navodilo za uporabo.
What are the risks associated with Seebri Breezhaler? 
Kakšna tveganja so povezana z zdravilom Seebri Breezhaler?
Muscarinic receptors control the contraction of muscles and when glycopyrronium bromide is inhaled, it relaxes the muscles of the airways. 
Muskarinski receptorji nadzirajo krčenje mišic in ob vdihu glikopironijevega bromida se mišice dihalnih poti sprostijo, kar pripomore, da ostanejo dihalne poti odprte, in omogoča bolniku, da lažje diha.
How is Seebri Breezhaler used? 
Kako se zdravilo Seebri Breezhaler uporablja?
How does Seebri Breezhaler work? 
Kako zdravilo Seebri Breezhaler deluje?
Seebri Breezhaler contains the active substance glycopyrronium bromide. 
Vsebuje zdravilno učinkovino glikopironijev bromid.
In both studies, 
KOPD.
Memantine LEK should be given once a day at the same time every day. 
Zdravilo Memantine LEK se daje enkrat dnevno, vsak dan ob istem času.
To prevent side effects, the dose of Memantine LEK is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day. 
Da se preprečijo neželeni učinki, se odmerek zdravila Memantine LEK v prvih treh tednih zdravljenja postopoma povečuje: prvi teden je odmerek 5 mg, drugi teden 10 mg, tretji teden pa 15 mg. Od četrtega tedna naprej je priporočeni vzdrževalni odmerek 20 mg enkrat dnevno.
The full EPAR for Memantine LEK 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 Memantine LEK je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Memantine LEK? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Memantine LEK?
Memantine LEK is a medicine used to treat patients with moderate to severe Alzheimer's disease, a type of dementia (a brain disorder) that gradually affects memory, intellectual ability and behaviour. 
Memantine LEK je zdravilo, ki se uporablja za zdravljenje bolnikov z zmerno do hudo Alzheimerjevo boleznijo, vrsto demence (možganske bolezni), ki postopoma prizadene spomin, intelektualno sposobnost in vedenje.
This means that Memantine LEK is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Ebixa.
This is a summary of the European public assessment report (EPAR) for Memantine LEK. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Memantine LEK.
The European Commission granted a marketing authorisation valid throughout the European Union for Memantine LEK on 22 April 2013. 
Evropska komisija je dovoljenje za promet z zdravilom Memantine LEK, veljavno po vsej Evropski uniji, odobrila dne 22. aprila 2013.
What are the benefits and risks of Memantine LEK? 
Kakšne so koristi in tveganja, povezani z zdravilom Memantine LEK?
The Committee recommended that Memantine LEK be approved for use in the EU. 
Priporočil je, da se zdravilo Memantine LEK odobri za uporabo v EU.
Memantine LEK is available as 10 mg and 20 mg tablets and can only be obtained with a prescription. 
Zdravilo Memantine LEK je na voljo v obliki 10- in 20-miligramskih tablet in se izdaja le na recept.
Because Memantine LEK is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Memantine LEK generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine LEK by the patient. 
Zdravljenje se sme uvesti samo, če je na voljo negovalec, ki bo redno spremljal bolnikovo jemanje zdravila Memantine LEK.
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine LEK has been shown to have comparable quality and to be bioequivalent to Axura. 
Odbor za zdravila za uporabo v humani medicini (CHMP), ki deluje pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Memantine LEK primerljivo raven kakovosti kot zdravilo Axura ter da mu je biološko enakovredno.
What is Memantine LEK and what is it used for? 
Kaj je zdravilo Memantine LEK in za kaj se uporablja?
For more information about treatment with Memantine LEK, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Memantine LEK preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Memantine LEK is a ‘generic medicine'. 
Zdravilo Memantine LEK je „generično“ zdravilo.
The tolerance and dose should be assessed within 3 months after starting treatment, and from then on the benefits of continuing treatment with Memantine LEK should be reassessed on a regular basis. 
Prenašanje in odmerek zdravila je treba oceniti v 3 mesecih od začetka zdravljenja, od takrat naprej pa je treba koristi zdravljenja z zdravilom
Safety information has been included in the summary of product characteristics and the package leaflet for Memantine LEK, including the appropriate precautions to be followed by healthcare professionals and patients. 
V povzetek glavnih značilnosti zdravila in navodilo za uporabo za zdravilo Memantine LEK so bile vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
For practical information about using Memantine LEK, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Memantine LEK naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Because Memantine LEK is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Axura. 
Ker je zdravilo Memantine LEK generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu Axura.
Other information about Memantine LEK 
Druge informacije o zdravilu Memantine LEK
It is not intended to provide practical advice on how to use Memantine LEK. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Therefore, the CHMP's view was that, as for Axura, the benefit outweighs the identified risk. 
Zato je menil, da njegove koristi, tako kot pri zdravilu Axura, odtehtajo znana tveganja.
Why is Memantine LEK approved? 
Zakaj je bilo zdravilo Memantine LEK odobreno?
The active substance in Memantine LEK, memantine, is an antidementia medicine. 
Zdravilna učinkovina zdravila Memantine LEK, memantin, je zdravilo za zdravljenje demence.
How has Memantine LEK been studied? 
Kako je bilo zdravilo Memantine LEK raziskano?
How is Memantine LEK used? 
Kako se zdravilo Memantine LEK uporablja?
How does Memantine LEK work? 
Kako zdravilo Memantine LEK deluje?
1 bottle + 1 adapter + 1 oral applicator 
1 plastenka + 1 nastavek za plastenko + 1 aplikator za peroralno odmerjanje
Oral solution bottle (HDPE) 230 ml 
Peroralna uporaba Plastenka (HDPE) 230 ml
(Invented) name Strength Pharmaceutical Form 
(Izmišljeno) ime
Content (concentration) Package size 
Farmacevtska oblika Pot uporabe Stična ovojnina Vsebina (koncentracija)
Should the use of existing data sources not show feasible, a proposal for a prospective collection of data should be provided. 
Če se izkaže, da uporaba obstoječih podatkovnih virov ni izvedljiva, je treba podati predlog za prospektivno
CHMP opinion and detailed explanation of the scientific grounds for the differences from the 
Mnenje odbora CHMP in podrobna obrazložitev znanstvene podlage za odstopanja od
As both requests for the triggered procedure result from the evaluation of data resulting from pharmacovigilance activities, the EC requested the opinion to be adopted by the Committee for Medicinal Products for Human Use (CHMP) on the basis of a recommendation of the Pharmacovigilance 
Ker sta obe zahtevi za sprožitev postopka posledica vrednotenja podatkov, ki izhajajo iz dejavnosti farmakovigilance, je Evropska komisija zaprosila Odbor za zdravila za uporabo v humani medicini (CHMP), da sprejme mnenje na podlagi priporočila Odbora za oceno tveganja na področju farmakovigilance (PRAC).
Having reviewed the PRAC recommendation, the CHMP agreed with the overall scientific conclusions 
Potem ko je odbor CHMP pregledal priporočilo odbora PRAC, se je strinjal s splošnimi znanstvenimi
Some of the cases identified with DAAs had serious outcomes, with worsening of hepatic status and at least one case where the patient 
Nekateri ugotovljeni primeri z neposredno delujočimi protivirusnimi učinkovinami so imeli resne izide, s poslabšanjem jetrnega statusa in vsaj enim primerom, ko je bolnik
The RMP should be updated accordingly within 3 months of this CHMP opinion. 
Načrt za obvladovanje tveganja je treba ustrezno posodobiti v treh mesecih po izdaji tega mnenja
In addition, patients should be advised to contact their doctor if they have ever been infected with HBV as close monitoring is required. 
Poleg tega je treba bolnikom svetovati, naj se obrnejo na zdravnika, če so bili kdaj okuženi z virusom hepatitisa B, saj je potrebno skrbno
The European Commission therefore extended the scope of the procedure in April 2016 to allow consideration of other data to assess the risk of hepatocellular carcinoma and its impact on the benefit-risk balance for all DAAs in the treatment of chronic hepatitis C. 
Evropska komisija je zato aprila 2016 razširila obseg postopka in vanj vključila še upoštevanje drugih podatkov za oceno tveganja za hepatocelularni karcinom in njegovega učinka na razmerje med tveganji in koristmi za vse neposredno delujoče protivirusne učinkovine pri
• The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for direct-acting antiviral agents (DAAs) indicated in the 
• odbor PRAC je obravnaval postopek v skladu s členom 20 Uredbe (ES) št. 726/2004, ki je bil na podlagi farmakovigilančnih podatkov sprožen za neposredno delujoče protivirusne učinkovine, indicirane za zdravljenje kroničnega hepatitisa C;
The product information will include a warning to inform about the risk of hepatitis B reactivation and 
Informacije o zdravilu bodo vključevale opozorilo za obveščanje o tveganju za reaktivacijo hepatitisa B in bodo odražale ta priporočila;
Following the initiation of this review, results from a study (Reig et al. 2016) performed between October 2014 and December 2015 in Hepatology Units of four University Spanish hospitals in patients with chronic hepatitis C and a history of hepatocellular carcinoma (HCC) treated with DAAs suggested 
Po začetku tega pregleda so rezultati študije (Reig in drugi, 2016), opravljene med oktobrom 2014 in decembrom 2015 na oddelkih za hepatologijo štirih španskih univerzitetnih bolnišnic pri bolnikih s kroničnim hepatitisom C in anamnezo hepatocelularnega karcinoma, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, pokazali nepričakovano hiter ponovni pojav hepatocelularnega
The European Association for the Study of the Liver (EASL) recommendations on treatment of hepatitis C makes reference to the potential risk of HBV reactivation during or after HCV clearance. 
Priporočila Evropskega združenja za bolezni jeter (EASL) o zdravljenju hepatitisa C navajajo morebitno tveganje za reaktivacijo virusa hepatitisa B ob ali po odstranitvi virusa
The CHMP, as a consequence, considers that the benefit-risk balance of Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax remains favourable subject to the amendments to the product information and to the conditions described above. 
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil Daklinza, Exviera, Harvoni, Olysio, Sovaldi in Viekirax še naprej ugodno, če se upoštevajo zgoraj opisane spremembe
The current referral procedure was triggered by the European Commission (EC) to allow further investigation of the risk of hepatitis B virus replication after starting treatment with DAAs and recommend any appropriate measure to 
Trenutni napotitveni postopek je sprožila Evropska komisija, da bi omogočila nadaljnjo preiskavo tveganja za razmnoževanje virusa hepatitisa B po začetku zdravljenja z neposredno delujočimi protivirusnimi učinkovinami in priporočila ustrezne ukrepe za zmanjšanje tveganja.
• The PRAC reviewed the totality of the data submitted in writing and during the oral explanations by the marketing authorisation holders in relation to the risk of hepatitis B reactivation and to the concerns raised following reports of hepatocellular carcinoma in patients using DAAs, as well as the outcome of the meeting of the scientific advisory group on HIV/Viral 
• odbor PRAC je pregledal vse podatke, ki so jih pisno in z ustno obrazložitvijo predložili imetniki dovoljenj za promet z zdravilom v povezavi s tveganjem za reaktivacijo hepatitisa B in s pomisleki, ki so se pojavili med poročili o hepatocelularnem karcinomu pri bolnikih, ki uporabljajo neposredno delujoče protivirusne učinkovine, ter izid sestanka znanstvene svetovalne skupine o HIV/virusnih boleznih;
Overall, the PRAC was of the view that evidence exists of a risk of HBV reactivation in HBV/HCV coinfected patients treated with DAAs and therefore HBV reactivation in co-infected patients should be considered as an important identified risk which should be closely monitored through routine risk 
Na splošno je odbor PRAC menil, da obstajajo dokazi o tveganju za reaktivacijo HBV pri bolnikih s sočasno okužbo s HBV/HCV, zdravljenih z neposredno delujočimi protivirusnimi učinkovinami, zato je treba reaktivacijo HBV pri bolnikih s sočasno okužbo upoštevati kot pomembno ugotovljeno tveganje, ki ga je treba skrbno spremljati z rutinskimi dejavnostmi za zmanjševanje tveganja.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax. 
Zato priporoča spremembo pogojev dovoljenj za promet z zdravili Daklinza, Exviera, Harvoni, Olysio,
In accordance with the PRAC recommendation, in order to evaluate the recurrence of hepatocellular carcinoma associated with direct-acting antivirals, the MAHs shall conduct and submit the results of a prospective safety study using data deriving from a cohort of a well-defined group of patients, based on an agreed protocol setting out criteria for entry and follow-up of patients in terms of timing and 
Da bi ovrednotili ponovitev hepatocelularnega karcinoma, povezano z neposredno delujočimi protivirusnimi učinkovinami, bodo imetniki dovoljenj za promet z zdravilom v skladu s priporočilom odbora PRAC opravili prospektivno študijo varnosti in predložili njene rezultate, in sicer z uporabo podatkov iz kohorte dobro opredeljene skupine bolnikov na podlagi dogovorjenega protokola, ki določa merila za vključitev in spremljanje bolnikov glede časa in metode presejalnega testiranja.
Therefore data on HBV reactivation with DAAs mostly arose post-marketing. 
Zato podatki o reaktivaciji virusa hepatitisa B z neposredno delujočimi protivirusnimi učinkovinami večinoma
20.5 - 25 ml 
Intravenska uporaba viala (steklena) 20.5 - 25 ml
1 ml (100 mg/ml) 3 (3 x 1) prefilled syringes (multipack) 
1 ml (100 mg/ml) 3 (3 x 1) napolnjeni injekcijski peresniki (večkratno pakiranje)
1 ml (100 mg/ml) 1 pre-filled syringe 
1 ml (100 mg/ml) 1 napolnjena injekcijska brizga
1 ml (100 mg/ml) 1 pre-filled pen 
1 ml (100 mg/ml) 1 napolnjen injekcijski peresnik
23 May 2013 
23. maj 2013
The opinion was converted into a Decision by the European Commission on 23 May 2013. 
Mnenje je bilo spremenjeno v Odločbo Evropske komisije dne 23. maja 2013.
The Committee appointed Prof. Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur. 
Odbor je imenoval prof. Christiana Friisa za poročevalca in dr. Cornelio Ibrahim za soporočevalko.
International non-proprietary name (INN): florfenicol 
Mednarodno nelastniško ime (INN): florfenikol
The decentralised procedure started on 17 December 2010. 
Decentralizirani postopek se je začel 17. decembra 2010.