natgillin/translations-raw huggingface dataset:
Once the patient has been stabilised, the maintenance dose may be reduced gradually if the patients agrees, and eventually treatment may be stopped.
Ko je bolnikovo stanje stabilno, se lahko vzdrževalni odmerek postopoma zmanjša, če se bolnik strinja, in zdravljenje navsezadnje zaključi.
Zubsolv is available as tablets of various strengths (0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg, 8.6 mg/2.1 mg, 11.4 mg/2.9 mg).
Zdravilo Zubsolv je na voljo v obliki tablet različnih jakosti (0,7 mg/0,18 mg, 1,4 mg/0,36 mg, 2,9 mg/0,71 mg, 5,7 mg/1,4 mg, 8,6 mg/2,1 mg, 11,4 mg/2,9 mg).
What is Zubsolv and what is it used for?
Kaj je zdravilo Zubsolv in za kaj se uporablja?
Sublingual tablets containing buprenorphine alone have been available in the EU since the mid-1990s for the treatment of opioid addiction.
Podjezične tablete, ki vsebujejo zgolj buprenorfin, so za zdravljenje zasvojenosti z opioidi v EU na voljo od sredine devetdesetih let prejšnjega stoletja.
It is not intended to provide practical advice on how to use Zubsolv.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The study also showed that Zubsolv tablets dissolved faster and had a better taste than the reference medicine.
Študija je pokazala tudi, da se tablete zdravila Zubsolv hitro raztopijo in imajo boljši okus kot referenčno zdravilo.
This is a summary of the European public assessment report (EPAR) for Zubsolv.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zubsolv.
What are the risks associated with Zubsolv?
Kakšna tveganja so povezana z zdravilom Zubsolv?
Zubsolv is a medicine used in adults and adolescents aged over 15 years to treat dependence on opioid (narcotic) drugs such as heroin or morphine.
Zdravilo Zubsolv je zdravilo, ki se uporablja pri odraslih in mladostnikih, starejših od 15 let, za zdravljenje odvisnosti od opioidov (narkotikov), kot sta heroin in morfin.
What benefits of Zubsolv have been shown in studies?
Kakšne koristi je zdravilo Zubsolv izkazalo v študijah?
Zubsolv is a ‘hybrid medicine'.
Zdravilo Zubsolv je „hibridno zdravilo“.
Zubsolv is used in individuals who are also receiving medical, social and psychological support and who have agreed to be treated for their addiction.
Zdravilo Zubsolv se uporablja pri osebah, ki prejemajo tudi zdravstveno, socialno in psihološko podporo ter so privolili v zdravljenje zasvojenosti.
A study involving 125 healthy volunteers showed that some strengths of the Zubsolv tablets produced a lower level of the active substances in the body than the reference product and therefore the two medicines cannot be used interchangeably.
Študija, ki je vključevala 125 zdravih prostovoljcev, je pokazala, da so nekatere jakosti tablet zdravila Zubsolv privedle do nižje ravni zdravilnih učinkovin v telesu kot referenčno zdravilo, zato teh dveh zdravil ni možno uporabljati izmenično.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zubsolv have been included in the summary of product characteristics and the package leaflet.
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zubsolv upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
It must also not be used with the medicines naltrexone and nalmefene, other opioid antagonists used for the treatment of alcohol or opioid dependence.
Prav tako se ne sme uporabljati skupaj z naltreksonom in nalmefenom, drugima opioidnima antagonistoma, ki se uporabljata za zdravljenje odvisnosti od alkohola in opioidov.
As for Suboxone, the European Medicines Agency decided that Zubsolv's benefits are greater than its risks and recommended that it be approved for use in the EU.
Kot za zdravilo Suboxone je Evropska agencija za zdravila zaključila, da so koristi zdravila Zubsolv večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
The company provided data from studies with the reference medicine Suboxone and from the published literature showing the benefits of buprenorphine and naloxone in the treatment of opioid dependence.
Družba je predložila podatke iz študij z referenčnim zdravilom Suboxone in iz objavljene literature, ki kažejo koristi buprenorfina in naloksona pri zdravljenju opioidne odvisnosti.
This means that it is similar to a ‘reference medicine' containing the same active substances, but Zubsolv contains these at different strengths.
To pomeni, da je podobno referenčnemu zdravilu, ki vsebuje enaki zdravilni učinkovini, vendar sta v zdravilu Zubsolv prisotni v večji jakosti.
Other information about Zubsolv
Druge informacije o zdravilu Zubsolv
For more information about treatment with Zubsolv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zubsolv preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Zubsolv contains two active substances: buprenorphine, a partial opioid agonist (it acts like an opioid drug but less powerfully), and naloxone, an opioid antagonist (it counteracts the effects of opioid drugs).
Zdravilo Zubsolv vsebuje dve zdravilni učinkovini: buprenorfin, ki je delni opioidni agonist (deluje kot opioidno zdravilo, vendar ni tako močno), in nalokson, ki je opioidni antagonist (izniči učinke opioidnih zdravil).
For practical information about using Zubsolv, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Zubsolv naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Zubsolv must not be used in patients with severe respiratory insufficiency (inability to breathe properly), severe liver problems, acute alcoholism (excessive alcohol consumption) or delirium tremens (a condition caused by alcohol withdrawal).
Zdravilo Zubsolv se ne sme uporabljati pri bolnikih s hudo respiratorno insuficienco (oslabljenim dihanjem), hudimi težavami z jetri, akutnim alkoholizmom (čezmernim uživanjem alkohola) ali stanjem delirium tremens (stanjem zaradi odtegnitve od alkohola).
The reference medicine for Zubsolv is Suboxone.
Referenčno zdravilo za zdravilo Zubsolv je zdravilo Suboxone.
The most common side effects with Zubsolv (which may affect more than 1 in 10 people) are constipation and symptoms of drug withdrawal such as insomnia (difficulty sleeping), headache, nausea (feeling sick), hyperhidrosis (excessive sweating) and pain.
Najpogostejši neželeni učinki zdravila Zubsolv (ki se lahko pojavijo pri več kot 1 osebi od 10) so zaprtost in odtegnitveni simptomi, kot so nespečnost, glavobol, navzeja (siljenje na bruhanje), hiperhidroza (pretirano znojenje) in bolečine.
Serious side effects include seizures (fits), vomiting, diarrhoea and abnormal results of blood tests for liver function.
Resni neželeni učinki obsegajo epileptične napade (krče), bruhanje, drisko in nenormalne rezultate krvnih preiskav za delovanje jeter.
Why is Zubsolv approved?
Zakaj je bilo zdravilo Zubsolv odobreno?
The addition of naloxone helps prevent the misuse of the medicine.
Z dodajanjem naloksona se prepreči možnost zlorabe tega zdravila.
Because Zubsolv can be misused or cause addiction, it can only be obtained by ‘special' prescription and must be used under the supervision of a doctor who has experience in the management of opioid addiction.
Bolniki lahko zdravilo Zubsolv zlorabijo, zdravilo pa povzroči zasvojenost, zato se predpisuje in izdaja samo na posebni recept ter ga je treba uporabljati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem odvisnosti od opioidov.
Combining buprenorphine and naloxone is an established strategy for managing opioid dependence which prevents misuse of the medicine.
Kombinacija buprenorfina in naloksona je uveljavljena strategija za obravnavo odvisnosti od opioidov, ki preprečuje zlorabo zdravila.
However, buprenorphine tablets have been misused by drug addicts who dissolve the tablets and inject themselves with the resulting solution.
Vendar pa so jih odvisniki od drog zlorabljali tako, da so jih raztopili in si dobljeno raztopino vbrizgali.
Since Zubsolv does not produce the same amounts of buprenorphine and naloxone in the blood as the reference medicine, the medicines cannot be used interchangeably.
Ker so ravni buprenorfina in naloksona v krvi po uporabi zdravila Zubsolv nižje kot po uporabi referenčnega zdravila, teh dveh zdravil ni možno uporabljati izmenično.
On the first day of treatment, the recommended daily dose is one or two tablets of Zubsolv 1.4 mg/0.36 mg or 2.9 mg/0.71 mg. During the next days, the doctor may increase the dose depending on the patient's response, but the daily dose should not be higher than 17.2 mg buprenorphine.
Priporočeni dnevni odmerek na prvi dan zdravljenja je ena ali dve tableti zdravila Zubsolv 1,4 mg/0,36 mg ali 2,9 mg/0,71 mg.
For the full list of side effects reported with Zubsolv, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Zubsolv, glejte navodilo za uporabo.
This is because, when injected, naloxone counteracts the effects of opioids, causing the patient to experience acute withdrawal symptoms.
Nalokson namreč učinkuje tako, da v primeru vbrizgavanja izniči delovanje opioidov in pri bolniku sproži akutne odtegnitvene simptome.
It contains the active substances buprenorphine and naloxone.
Vsebuje zdravilni učinkovini buprenorfin in nalokson.
How is Zubsolv used?
Kako se zdravilo Zubsolv uporablja?
How does Zubsolv work?
Kako zdravilo Zubsolv deluje?
90 capsules blister (PVC/Aclar/alu)
90 kapsul peroralna uporaba pretisni omot (PVC/Aclar/alu)
Annex A_en
Annex A_sl
MA (EU) Number
Št. (EU) dovoljenja za promet
bene-Arzneimittel GmbH
90 (9x10) kapsul peroralna uporaba plastenka (HDPE)) 300 (3x100) kapsul bene-Arzneimittel GmbH
MA (EU) number
Številka (EU)
(Invented) name
(Izmišljeno)
17 February 2011 EMA/121971/2011 EMEA/H/C/002091
17. februar 2011 EMA/121971/2011 EMEA/H/C/002091
The application was withdrawn before ‘day 120'.
Vlogo so umaknili pred 120. dnevom.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Dopis, s katerim družba agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“ (Vsi dokumenti).
The company provided data from the published literature on topotecan.
Družba je predložila podatke iz objavljene literature o topotekanu.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations.
Ker je CHMP takrat še ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
This means that the CHMP was still evaluating the initial documentation provided by the company.
To pomeni, da je CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
• metastatic cancer of the ovary (when the cancer has spread to other parts of the body) after at least one other treatment has failed;
• metastatskim rakom jajčnikov (kadar se je rak razširil tudi na druge dele telesa) po neuspešnem zdravljenju z vsaj enim drugim zdravilom;
On 3 January 2011, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Topotecan SUN for the treatment metastatic cancer of the ovary, small cell lung cancer and cervical cancer.
je dne 3. januarja 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za dovoljenje za promet z zdravilom Topotecan SUN, namenjenim za zdravljenje metastatskega raka jajčnikov, drobnoceličnega pljučnega raka in raka materničnega vratu.
It was also to be used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer had come back after radiotherapy, or when the disease was at an advanced stage (stage IVB: the cancer has spread beyond the cervix).
Zdravilo naj bi se uporabljalo tudi skupaj s cisplatinom (druga vrsta zdravila proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak ponovno pojavil po že končanem zdravljenju z obsevanjem ali če je bila bolezen v napredovalem stadiju (stadij IVB: rak se je razširil prek meja materničnega vratu).
This means that Topotecan SUN was intended to be similar to a ‘reference medicine' already authorised in the European Union called Hycamtin.
To pomeni, da naj bi bilo zdravilo Topotecan SUN podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji, in sicer zdravilu Hycamtin.
• small cell lung cancer, when the cancer has relapsed (come back).
• drobnoceličnim pljučnim rakom, kadar se je rak ponovno pojavil (relaps).
Topotecan SUN was to be used on its own to treat patients with:
Zdravilo Topotecan SUN naj bi se uporabljalo samostojno za zdravljenje bolnikov z:
Topotecan SUN was developed as a ‘generic medicine'.
Zdravilo Topotecan SUN je bilo razvito kot „generično zdravilo“.
Withdrawal of the marketing authorisation application for Topotecan SUN (topotecan)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Topotecan SUN (topotekan)
Topotecan SUN also affects non-cancer cells, which causes side effects.
Zdravilo Topotecan SUN vpliva tudi na nerakaste celice, kar povzroča neželene učinke.
What were the reasons given by the company for withdrawing the application?
Kakšni so bili razlogi družbe za umik vloge
This prevents the cancer cells from dividing and they eventually die.
To rakastim celicam preprečuje deljenje in sčasoma odmrejo.
When the enzyme is blocked, the DNA strands break.
Z zaviranjem delovanja encima začnejo verige DNK razpadati.
It contains the active substance topotecan.
Vsebuje zdravilno učinkovino topotekan.
The active substance in Topotecan SUN, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Zdravilna učinkovina v zdravilu Topotecan SUN, topotekan, je zdravilo proti raku, ki sodi v skupino „zaviralcev topoizomeraze“.
It blocks an enzyme called topoisomerase I, which is involved in the division of DNA.
Zdravilo zavira encim, imenovan topoizomeraza I, ki sodeluje v procesu deljenja DNK.
What is Topotecan SUN?
Kaj je zdravilo Topotecan SUN?
Topotecan SUN is a powder to be made up into a solution for infusion (drip into a vein).
Zdravilo Topotecan SUN je prašek, ki se pripravi v raztopino za infundiranje (kapalna infuzija v veno).
How is Topotecan SUN expected to work?
Kako naj bi zdravilo Topotecan SUN delovalo?
No additional studies were needed as Topotecan SUN is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Hycamtin.
Ker je zdravilo Topotecan generično zdravilo, ki se daje z infuzijo in vsebuje enako zdravilno učinkovino kot referenčno zdravilo Hycamtin, niso bile potrebne nobene dodatne študije.
What was Topotecan SUN expected to be used for?
Za kaj naj bi se zdravilo Topotecan SUN uporabljalo?
There are no specific risks for the user.
Za uporabnika ni posebnih tveganj.
Milk can be taken immediately.
Mleko se lahko uporabi takoj.
This summary was last updated on 27 January 2011.
Ta povzetek je bil nazadnje posodobljen dne 27/01/2011.
This will help to protect against the disease.
To pomaga pri obrambi pred boleznijo.
This slight swelling lasts for less than a day in most cases.
Rahla oteklina traja v večini primerov manj kot en dan.
This increase can sometimes be higher (up to 1.6º C in adult cows and up to 2.2º C in calves).
To povišanje je v nekaterih primerih lahko višje (do 1,6°C pri odraslih kravah in do 2,2°C pri teletih).
The rise in temperature is temporary and spontaneously resolved within two days without treatment.
Povišanje telesne temperature je začasno in brez zdravljenja spontano izzveni v dveh dneh.
The virus is alive, but it has also been attenuated (weakened) to further lower its ability to cause infection.
Virus je živ, vendar oslabljen, zaradi česar je še nadalje zmanjšana možnost, da povzroči okužbo.
The efficacy of the vaccine was studied in three laboratory studies including one study looking at the duration of immunity.
Učinkovitost cepiva je bila raziskana v treh laboratorijskih študijah, vključno z eno, ki je raziskala trajanje imunosti.
Afterward a single ‘booster' can be given every six months to maintain the vaccine's effect.
Vsakih šest mesecev je treba nato dati spodbujevalni odmerek za vzdrževanje učinka cepiva.
The first injection can be given to calves from three months of age.
Prvo injekcijo lahko prejmejo teleta od starosti treh mesecev dalje.
What is the time to allow before milk can be taken from the animal for human consumption?
Koliko časa je treba počakati, preden se mleko živali uporabi za prehrano ljudi?
This vaccine is a marker vaccine and can enable a differential testing of vaccinated and naturally infected cattle, which is a useful tool in eradication campaigns.
To cepivo je marker cepivo, ki lahko omogoči razlikovalno testiranje cepljenega in naravno okuženega goveda, kar je pomembno orodje pri ukrepih zatiranja bolezni.
In the future, if the animals are exposed to the IBR virus, the immune system will be able to respond more quickly.
Ob ponovni izpostavitvi virusu IBR v prihodnosti se bo imunski sistem tako hitreje odzval.
The vaccine is given to animals as two injections, three weeks apart, into the neck muscles.
Cepivo se daje živalim v obliki dveh injekcij v vratne mišice v razmiku treh tednov.
Studies also looked at the safety of the vaccine in pregnant animals.
V študijah so raziskovali tudi varnost cepiva pri brejih živalih.
After vaccination, animals may show a slight increase in body temperature up to 1° C, in the four days following vaccination.
V štirih dneh po cepljenju se lahko pri živalih telesna temperatura poviša za največ 1°C .
The European Commission granted a marketing authorisation valid throughout the European Union, for Hiprabovis IBR Marker Live to Laboratorios Hipra S.A. on 27 January 2011.
Evropska komisija je dovoljenje za promet z zdravilom Hiprabovis IBR Marker Live, veljavno po vsej Evropski uniji, odobrila družbi Laboratorios Hipra S.A. dne 27/01/2011.
The injections should be preferably administered on the alternate sides of the neck.
Po možnosti naj se injiciranje opravlja izmenoma na obeh straneh vratu.
The studies also showed that the vaccine can be used in pregnant cattle as well in the presence of maternally derived antibodies.
Študije so pokazale tudi, da se cepivo lahko uporablja pri brejih živalih, kot tudi ob prisotnosti maternalnih protiteles.
The safety of Hiprabovis IBR Marker Live was investigated in a number of laboratory studies and in one field trial that included dairy cows and fattening cattle.
Varnost cepiva Hiprabovis IBR Marker Live je bila raziskana v številnih laboratorijskih študijah in v enem preskušanju na terenu, kjer so bile vključene krave molznice in govedo za pitanje.
It is a powder for suspension for injection that contains a modified live infectious bovine rhinotracheitis (IBR) virus (also known as Bovine Herpes Virus type 1).
Na voljo je v obliki praška za suspenzijo za injiciranje, ki vsebuje prirejen živ virus infekcioznega bovinega rinotraheitisa (IBR), znanega tudi kot goveji herpes virus vrste 1).
Hiprabovis IBR Marker Live is a vaccine that contains an IBR virus that has been genetically modified to delete two genes so that the virus is less ‘pathogenic' (less able to cause a disease).
Zdravilo Hiprabovis IBR Marker Live je cepivo, ki vsebuje genetsko spremenjen virus IBR z dvema izbrisanima genoma, zaradi česar je manj patogen (manj zmožen povzročiti bolezen).
What is the time to allow before the animal can be slaughtered and the meat used for human consumption (withdrawal period)?
Koliko časa mora preteči, preden se lahko žival zakolje in meso porabi za prehrano ljudi (karenca)?
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Hiprabovis IBR Marker Live exceed the risks for the active immunisation of cattle from three months of age against Bovine Herpes Virus type 1 to reduce the clinical signs of infectious bovine IBR and field virus excretion and recommended that Hiprabovis IBR Marker Live be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Hiprabovis IBR Marker Live večje od z njim povezanih tveganj pri aktivni imunizaciji goveda od tretjega meseca starosti proti govejemu herpes virusu vrste 1 za zmanjšanje kliničnih znakov infekcioznega bovinega rinotraheitisa in izločanja virusa ter je priporočil, da se za zanj odobri dovoljenje za promet.
Live vaccine against infectious bovine rhinotracheitis (IBR)
Živo cepivo proti infekcioznemu bovinemu rinotraheitisu (IBR)
Hiprabovis IBR Marker Live is used to vaccinate cattle (cows and calves) against the respiratory infections caused by IBR.
Cepivo Hiprabovis IBR Marker Live se uporablja za cepljenje govedi (krav in telet) proti respiratornim okužbam, ki jih povzroča IBR.
The vaccine is used to reduce the clinical signs of IBR and the excretion (shedding) of the virus by the infected animals.
Cepivo se uporablja za zmanjšanje kliničnih znakov IBR in izločanja virusa pri okuženih živalih.
The studies showed that the vaccine is safe for cattle from three months of age and that it reduces the clinical signs of IBR and field virus excretion.
Študije so pokazale, da je cepivo varno od tretjega meseca dalje in da zmanjša klinične znake IBR ter izločanje virusa.
Hiprabovis IBR Marker Live is a vaccine.
Zdravilo Hiprabovis IBR Marker Live je cepivo.
A field study also looked at the efficacy of Hiprabovis IBR Marker Live, compared with a dummy vaccine, on reducing the clinical signs of the disease and virus excretion.
Terenska študija je raziskala tudi učinkovitost cepiva Hiprabovis IBR Marker Live pri zmanjševanju kliničnih znakov bolezni in izločanja virusa v primerjavi s cepivom brez aktivne učinkovine.
When Hiprabovis IBR Marker Live is given to cattle, the animals' immune systems recognise the viruses as ‘foreign' and make defences against it.
Ko govedo cepimo, imunski sistem živali virus prepozna kot „tujek“ in proti njemu razvije obrambo.
Animals can also show a temporary inflammation at the site of injection in the 72 hours after-vaccination.
V 72 urah po cepljenju se lahko pojavi tudi vnetje na mestu injiciranja.
Other information about Hiprabovis IBR Marker Live:
Druge informacije o zdravilu Hiprabovis IBR Marker Live:
What benefit has Hiprabovis IBR Marker Live shown during the studies?
Kakšne koristi je zdravilo Hiprabovis IBR Marker Live izkazalo med študijami?
Why has Hiprabovis IBR Marker Live been approved?
Zakaj je bilo zdravilo Hiprabovis IBR Marker Live odobreno?
What is the risk associated with Hiprabovis IBR Marker Live?
Kakšna tveganja so povezana z zdravilom Hiprabovis IBR Marker Live?
The withdrawal period is zero days.
Obdobje karence zdravila je nič dni.
How has Hiprabovis IBR Marker Live been studied?
Kako je bilo zdravilo Hiprabovis IBR Marker Live raziskano?
What is Hiprabovis IBR Marker Live used for?
Za kaj se zdravilo Hiprabovis IBR Marker Live uporablja?
How does Hiprabovis IBR Marker Live work?
Kako zdravilo Hiprabovis IBR Marker Live deluje?
What is Hiprabovis IBR Marker Live?
Kaj je zdravilo Hiprabovis IBR Marker Live?
The European Commission issued a decision on 14 July 2009.
Evropska komisija je odločbo izdala dne 14. julija 2009.
1 Article 29 of Directive 2001/83/EC as amended, referral on the grounds of potential serious risk to public health
Člen 29 Direktive 2001/83/ES, kakor je bila spremenjena, napotitev na podlagi možnega resnega tveganja za javno zdravje.
Ref. EMEA/CHMP/499991/2009 EMEA/H/A-29/1061
: EMEA/495517/2009 EMEA/H/A-29/1061
Prof Pirożynski (Poland)
Prof. Pirożynski (Poljska)
The company wanted the authorisation to be recognised in Latvia, Lithuania, Poland, Slovakia and Slovenia (the ‘concerned Member States').
Družba je želela, da se odobritev za promet prizna v Latviji, Litvi, na Poljskem, Slovaškem in v Sloveniji (zadevne države članice).
Dr van Zwieten-Boot (Netherlands)
Dr. van Zwieten-Boot (Nizozemska)