natgillin/translations-raw huggingface dataset:
Do not start taking Activelle: • If you are allergic (hypersensitive) to estradiol, norethisterone acetate or any of the other ingredients of Activelle (listed in section 6,“Further information”). • If you have or have had breast cancer, or if it is suspected • If you have cancer of the womb lining (endometrium), or if such an oestrogen dependent cancer is suspected • If you have any vaginal bleeding, which has not been diagnosed by your doctor • If you have endometrial hyperplasia (excessive growth of the womb lining) that is not being treated • If you have a blood clot (like deep vein thrombosis or lung embolism) or previously have had a blood clot without obvious cause, e.g. in connection with surgery or pregnancy • If you have recently had a heart attack, stroke, or have angina • If you have or have had a liver disorder and your liver tests have not returned to normal • If you have porphyria (a liver enzyme disease)
Ne začnite jemati zdravila Activelle, če: • ste alergični na (preobčutljivi za) estradiol, noretisteronacetat ali katero koli drugo sestavino zdravila Activelle (sestavine so naštete v poglavju 6, "Dodatne informacije"), • imate ali ste kdaj imeli raka na dojki, ali če obstaja sum nanj, • imate raka na maternični sluznici (endometriju) ali če obstaja sum na takšnega, od estrogenov odvisnega raka, • imate krvavitve iz nožnice, katerih vzroka zdravnik še ni ugotovil, • imate nezdravljeno hiperplazijo endometrija (čezmerno rast maternične sluznice), • imate krvni strdek (npr. globoko vensko trombozo ali pljučno embolijo) ali ste takšen strdek imeli kdaj v preteklosti in brez očitnega vzroka, npr. v povezavi z operacijo ali nosečnostjo, • ste pred nedavnim imeli srčni infarkt, možgansko kap ali imate angino pektoris, • imate ali ste imeli kakšno bolezen jeter in se izvidi jetrnih testov še niso normalizirali, 29 • imate porfirijo (posebno bolezen jetrnih encimov).
31 If you have (or have had) any of the following conditions, tell your doctor.
Bodite posebno pozorni pri jemanju zdravila Activelle Če imate (ali ste kdaj imeli) kaj od naslednjega, morate to povedati svojemu zdravniku.
• If you have any condition affecting the womb lining, such as myoma (benign tissue tumour), endometriosis (presence of womb lining tissue outside the womb) or have had endometrial hyperplasia (excessive growth of the womb lining) • If you have a history of blood clots (thrombosis) or have risk factors for blood clots (these risk factors and symptoms for a blood clot are listed in section 4,“Other side effects of combined HRT”) • If any of your immediate family has had breast cancer, or other cancers related to oestrogen (endometrial cancer) • If you have high blood pressure • If you have a liver disorder such as liver adenoma (a benign tumour) • If you have a kidney or heart disorder • If you have diabetes or gallstone disease • If you have epilepsy or asthma • If you get migraines or severe headaches • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems) • If you have high levels of fat in the blood (hypertriglyceridemia) • If you have otosclerosis (hearing loss sometimes linked to pregnancy).
• če imate kakršne koli spremembe maternične sluznice, npr. miome (benigne tumorje tkiva), endometriozo (prisotnost tkiva maternične sluznice zunaj maternice) ali hiperplazijo endometrija (čezmerno rast maternične sluznice), • če ste kdaj imeli krvne strdke (trombozo) ali imate dejavnike tveganja za krvne strdke (ti dejavniki tveganja in simptomi krvnih strdkov so navedeni v poglavju 4, "Drugi neželeni učinki kombiniranega HNZ"), • če je kdo od vaših bližnjih sorodnikov imel raka na dojki ali druge vrste raka, povezane z estrogenom (rak na endometriju), • če imate visok krvni tlak, • če imate kakšno bolezen jeter, npr. adenom (benigen tumor) na jetrih, • če imate kakšno bolezen ledvic ali srca, • če imate sladkorno bolezen ali žolčne kamne, • če imate epilepsijo ali astmo, • če se vam pojavijo migrene ali hudi glavoboli, • če imate sistemski eritematozni lupus (avtoimunsko bolezen veziva, ki lahko prizadene številne organe), • če imate visoko koncentracijo maščob v krvi (hipertrigliceridemijo), • če imate otosklerozo (slabšanje sluha, včasih povezano z nosečnostjo).
Medical check-ups Before you start taking Activelle, your doctor will inform you about the risks and benefits of the treatment (see also section 4, “Other side effects of combined HRT”).
Zdravniški pregledi Pred začetkom jemanja zdravila Activelle vas bo zdravnik seznanil s tveganji in koristmi tega zdravljenja (glejte tudi poglavje 4, "Drugi neželeni učinki kombiniranega HNZ").
As well as regular check-ups with your doctor, be sure to: • Regularly check your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel • Go for regular breast screening (mammography) and cervical smear tests.
Poleg rednih pregledov pri zdravniku ne pozabite: • na redno samopregledovanje dojk, namenjeno odkrivanju sprememb, npr. nagubanosti ali udrtosti kože, sprememb na bradavici ali bul, ki jih lahko vidite ali otipljete, • na redna presejalna slikanja dojk (mamografijo) in brise materničnega vratu.
Stop taking Activelle If you are experiencing any of the following conditions below, stop taking Activelle, and contact your doctor immediately: • If you get a migraine-type headache for the first time • If you develop yellow skin or eyes (jaundice) or other liver problems • If your blood pressure goes up while you’re taking Activelle • If you become pregnant • If any of the conditions listed in section 2,“Do not take Activelle”, occur.
Nehajte jemati zdravilo Activelle Nehajte jemati zdravilo Activelle in se nemudoma posvetujte z zdravnikom, če: • se vam prvič pojavi migrenski glavobol, • vam porumenijo koža ali očesna beločnica (zlatenica) ali se pojavijo druge težave z jetri, • se vam med jemanjem zdravila Activelle zviša krvni tlak, • zanosite, • se vam pojavi katero koli stanje, navedeno v poglavju 2, "Ne jemljite zdravila Activelle".
32 • Medicines used for epilepsy (such as phenobarbital, phenytoin and carbamazepin) • Medicines used for tuberculosis (such as rifampicin, rifabutin) • Medicines used for HIV infections (such as nevirapine, efavirenz, ritonavir and nelfinavir) • Herbal products containing St John’s Wort (Hypericum perforatum).
30 Jemanje drugih zdravil Nekatera zdravila lahko zmanjšajo učinke zdravila Activelle: • zdravila proti epilepsiji (npr. fenobarbital, fenitoin in karbamazepin), • zdravila proti tuberkulozi (npr. rifampicin, rifabutin), • zdravila proti okužbi s HIV (npr. nevirapin, efavirenz, ritonavir in nelfinavir), • zeliščni pripravki, ki vsebujejo šentjanževko (Hypericum perforatum).
Activelle contains lactose.
Pomembne informacije o nekaterih sestavinah zdravila Activelle Zdravilo Activelle vsebuje laktozo.
Always take Activelle exactly as your doctor has told you.
Natančno upoštevajte zdravnikova navodila.
Take one tablet once a day, at about the same time each day Take the tablet with a glass of water.
Tableto vzemite s kozarcem vode.
If you take more Activelle than you should If you have taken more Activelle than you should, or if for example a child has taken Activelle accidentally, talk to your doctor or hospital to assess the risk and for advice.
Če ste vzeli večji odmerek zdravila Activelle, kot bi smeli Če ste vzeli večji odmerek zdravila Activelle, kot bi smeli, ali če je zdravilo po naključju zaužil otrok, se obrnite na zdravnika ali bolnišnico, da boste izvedeli, kolikšno je tveganje, in da boste dobili nasvet.
If you forget to take Activelle If you forget to take your tablet at the usual time, take it within the next 12 hours.
31 Če ste pozabili vzeti zdravilo Activelle Če ste pozabili pravočasno vzeti tableto, jo vzemite v naslednjih 12 urah.
33 Forgetting a dose may increase the likelihood of breakthrough bleeding and spotting unless you have had your womb removed.
Pozabljen odmerek poveča verjetnost vmesne krvavitve in krvavkastega izcedka (razen če so vam odstranili maternico).
If you stop taking Activelle If you want to stop taking Activelle, talk to your doctor first.
Če ste prenehali jemati zdravilo Activelle Če želite opustiti jemanje zdravila Activelle, se najprej posvetujte z zdravnikom.
Bleeding with Activelle Activelle will not cause regular monthly bleeding, but when first starting the tablets, many women experience slight vaginal bleeding or spotting.
Krvavitve med uporabo zdravila Activelle Zdravilo Activelle ne povzroča rednih mesečnih krvavitev, toda na začetku jemanja se pri številnih ženskah pojavi rahla krvavitev iz nožnice ali krvavkast izcedek.
But contact your doctor as soon as possible: • If bleeding carries on for more than the first few months • If bleeding starts after taking HRT for a while • If bleeding continues after stopping HRT.
Z zdravnikom se posvetujte čim prej, če: • se krvavitve nadaljujejo več kot prvih nekaj mesecev, • se krvavitve pojavijo potem ko že nekaj časa uporabljate HNZ, • se krvavitve nadaljujejo po prenehanju uporabe HNZ.
Very common (affects more than 1 user in 10) Common (affects 1 to 10 users in 100) Uncommon (affects 1 to 10 users in 1,000) Rare (affects 1 to 10 users in 10,000) Very rare (affects less than 1 user in 10,000) Not known (frequency cannot be estimated from the available data).
Pogostnost neželenih učinkov, navedenih v nadaljevanju, je definirana v skladu z naslednjim dogovorom: zelo pogosti (pojavijo se pri več kot 1 od 10 bolnic) pogosti (pojavijo se pri 1 do 10 bolnic od 100) občasni (pojavijo se pri 1 do 10 bolnic od 1. 000) redki (pojavijo se pri 1 do 10 bolnic od 10. 000) zelo redki (pojavijo se pri manj kot 1 od 10. 000 bolnic) neznana (ni mogoče oceniti iz razpoložljivih podatkov)
Common side effects • Fungal infection of the genitals or vaginal inflammation • Excessive growth of the womb lining (endometrial hyperplasia) • Feeling sick • Abdominal (stomach) pain • Pain in back or neck • Pain in arms or legs • Headache.
Pogosti neželeni učinki • glivične okužbe spolovil ali vnetje nožnice • čezmerna rast maternične sluznice (hiperplazija endometrija) • občutek slabosti • bolečine v trebuhu • bolečine v hrbtu ali vratu • bolečine v rokah ali nogah • glavobol
34 • Heartburn (dyspepsia) • Acne • Hair loss • Itching or urticaria.
Občasni neželeni učinki
Other side effects of combined HRT
32 • alergijska reakcija (preobčutljivost) • depresija ali poslabšanje obstoječe depresije • živčnost • omotica • migrena (glejte “ Nehajte jemati zdravilo Activelle ” v poglavju 2) • bolečine v dojkah ali nelagodje v dojkah • otekanje ali nelagodje v trebuhu • povečanje telesne mase zaradi zastajanja tekočine • otekanje rok in nog (periferni edemi) • krči v nogah • zgaga (dispepsija) • akne • izpadanje las • srbenje ali koprivnica
The following side effects have been reported after taking medicines containing oestrogen/progestagens.
Drugi neželeni učinki kombiniranega HNZ Po uporabi estrogensko- progestagenskih zdravil so opisani naslednji neželeni učinki:
Excessive growth of the womb lining (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer) In women with an intact womb, the risk of excessive growth of the womb lining (endometrial hyperplasia) is increased.
Čezmerna rast maternične sluznice (hiperplazija endometrija) in rak maternične sluznice (rak na endometriju) Pri ženskah z ohranjeno maternico se poveča tveganje za čezmerno rast maternične sluznice (hiperplazijo endometrija).
Breast cancer Every woman is at risk of getting breast cancer whether or not she takes HRT.
Rak na dojki Rak na dojki ogroža vsako žensko, ne glede na to, ali uporablja HNZ ali ne.
Blood clots in the deep veins Every woman is at risk of getting a blood clot whether or not she takes HRT.
Krvni strdki v globokih venah Krvni strdki ogrožajo vsako žensko, ne glede na to, ali uporablja HNZ ali ne.
HRT may increase the risk of blood clots 2-3 times in the veins, especially in the first year of treatment.
HNZ lahko poveča tveganje za krvne strdke v venah za 2 - do 3- krat, zlasti v prvem letu uporabe.
You are also more likely to get a blood clot: • If you are very overweight • If you have had a blood clot before, or have had any blood clotting problem that needed treatment with a medicine such as Warfarin • If any of your close family has had blood clots • If you have had a miscarriage • If you are bed-ridden for a longer period through surgery, injury or illness • If you have systemic lupus erythematosus (SLE, autoimmune collagen disease, which may affect many organ systems)
Verjetnost za pojav krvnega strdka je večja tudi, če: • ste pretežki, • ste imeli krvni strdek kdaj prej ali ste imeli kakršno koli težavo s strjevanjem krvi, ki je zahtevala zdravljenje z zdravili, kakršno je varfarin, • je imel krvne strdke kdo od vaših najbližjih sorodnikov, • ste kdaj imeli spontan splav, • ste zaradi operacije, poškodbe ali bolezni za daljši čas priklenjeni na posteljo, • imate sistemski eritematozni lupus (avtoimunsko bolezen veziva, ki lahko prizadene številne organe).
You may be at risk of having a blood clot if you get: • Painful swelling in your leg • Sudden chest pain • Difficulty breathing.
Nevarnost, da imate krvni strdek, obstaja, če se vam pojavijo: • boleča oteklina na nogi, • nenadne bolečine v prsih, • težko dihanje.
Stop taking HRT until your doctor says you can take it again.
Prenehajte jemati HNZ in ga ne uporabljajte, dokler vam zdravnik ne pove, da ga lahko.
Heart disease If you ever have had angina or heart attack, you should talk to your doctor about the risks and benefits of HRT.
33 Bolezen srca Če ste kdaj imeli angino pektoris ali srčni infarkt, se morate z zdravnikom pogovoriti o tveganjih in koristih HNZ.
Results from two clinical studies showed that women, who used another type of oestrogen/progestagen combination than the one in Activelle, had a slightly increased risk of cardiovascular disease in the first year of use.
Izsledki kliničnih študij so pokazali malenkost večje tveganje za srčnožilne bolezni v prvem letu uporabe pri ženskah, ki so jemale drugačno estrogensko- progestagensko kombinacijo, kot jo vsebuje zdravilo Activelle.
35 For other HRT products there are only limited data from trials examining the effects on the risk of cardiovascular disease.
O drugih zdravilih za HNZ je le malo podatkov iz raziskav, ki so proučevale tveganje za srčnožilne bolezni.
Stroke There may be a slightly higher risk of having a stroke if you are taking HRT.
Možganska kap Če uporabljate HNZ, morda obstaja malenkost večje tveganje za možgansko kap.
Other factors that also increase the risk of stroke are: • Getting older • High blood pressure • Smoking • Drinking too much alcohol • An irregular heartbeat.
Drugi dejavniki, ki prav tako povečujejo tveganje za možgansko kap, so: • višja starost, • visok krvni tlak, • kajenje, • čezmerno pitje alkoholnih pijač, • nereden srčni utrip.
If you get: • Unexplained migraine-type headaches, with or without disturbed vision.
Če se pojavijo: • nepojasnjeni migrenski glavoboli, z motnjami vida ali brez njih, čim prej pojdite k zdravniku.
Ovarian cancer There are some evidence from clinical studies that use of oestrogen-only products for more than 5 years increases the risk of ovarian cancer among women who have had their womb removed.
Rak na jajčniku Nekateri izsledki kliničnih študij kažejo, da več kot 5- letna uporaba zdravil, ki vsebujejo zgolj estrogen, povečuje tveganje za raka na jajčniku pri ženskah z odstranjeno maternico.
Dementia There is no evidence that HRT improves processes of remembering, learning and judging (cognitive function).
Demenca Ni dokazov, da HNZ izboljšuje zmožnost za pomnjenje, učenje in presojanje (kognitivne funkcije).
From a clinical study there is some evidence for an increased risk of dementia among women older than 65 years, who started using another type of oestrogen/progestagen combination than the one in Activelle.
Izsledki ene klinične študije so nakazali večje tveganje za demenco pri ženskah, ki so začele po 65. letu uporabljati neko drugo estrogensko- progestagensko kombinacijo, ne zdravila Activelle.
Gall bladder disease Gall bladder disease has been reported after treatment with oestrogen/progestagen.
Bolezen žolčnika Po zdravljenju z estrogeni/ progestageni je opisana bolezen žolčnika.
Effects on the skin Brown pigmented patches in the face, redness of the skin including inflammation on the hands or the legs (erythema multiforme), hump rose or a bruise-like rash.
Vpliv na kožo Rjavo obarvane lise po obrazu, pordelost kože z vnetjem dlani ali nog (multiformni eritem), vozličaste vnetne spremembe ali podplutbam podoben izpuščaj.
Do not use Activelle after the expiry date which is stated on the label and outer carton after “EXP”.
Zdravila Activelle ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji ovojnini za oznako "Upor. do:".
Medicines should not be disposed of via waste water or household waste.
34 Vsebnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
36 What Activelle contains • The active substances are estradiol and norethisterone acetate.
Kaj vsebuje zdravilo Activelle Zdravilni učinkovini sta estradiol in noretisteronacetat.
Each tablet contains 0.5 mg estradiol (as hemihydrate) and 0.1 mg norethisterone acetate. • Other ingredients are:
Ena tableta vsebuje 0, 5 mg estradiola (v obliki hemihidrata) in 0, 1 mg noretisteronacetata.
Lactose monohydrate, maize starch, hydroxypropylcellulose, magnesium stearate, hypromellose, triacetin and talc.
Pomožne snovi so laktoza, koruzni škrob, hidroksipropilceluloza, magnezijev stearat, hipromeloza, triacetin in smukec.
What Activelle looks like and contents of the pack The film-coated tablets are white, round with a diameter of 6 mm.
Izgled zdravila Activelle in vsebina pakiranja Filmsko obložene tablete so bele, okrogle, s premerom 6 mm.
The tablets are imprinted NOVO 291 on one side and the Novo Nordisk logo (an Apis bull) on the other side.
Tablete imajo na eni strani vtisnjen napis NOVO 291, na drugi strani pa logotip družbe Novo Nordisk (bika Apisa).
28 film-coated tablets 3 x 28 film-coated tablets Not all pack sizes may be marketed.
- 3 x 28 filmsko obloženih tablet.
Marketing authorisation holder and manufacturer
Način izdaje zdravila Activelle Izdaja zdravila je le na recept.
[See Annex I - To be completed nationally]
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - Izpolni država članica]
This medicinal product is authorized in the Member States of the EEA under the following names:
Zdravilo je v državah članicah EGP pridobilo dovoljenje za promet z naslednjimi imeni:
Austria - Noviana 0,5mg/0,1mg filmtabletten Belgium - Activelle minor comprimés pelliculés Bulgaria - Noviana™ филмирани таблетки Czech Republic - Noviana potahované tablety Denmark - Activelle low filmovertrukne tabletter Estonia - Activelle low 0,5 mg/0,1 mg õhukese polümeerikattega tablett Finland - Activelle 0,5 mg/0,1 mg tabl.
Avstrija - Noviana 0, 5mg/ 0, 1mg filmtabletten Belgija - Activelle minor comprimés pelliculés Bolgarija - Noviana™ филмирани таблетки Češka - Noviana potahované tablety Danska - Activelle low filmovertrukne tabletter Estonija - Activelle low 0, 5 mg/ 0, 1 mg õhukese polümeerikattega tablett Finska - Activelle 0, 5 mg/ 0, 1 mg tabl.
France - Activelle 0,5 mg/0,1 mg comprimé pelliculé Germany - Noviana Hungary - Noviana filmtabletta Iceland - Activelle® low 0.5 mg/0.1 mg tablets filmuhúðaðar töflur Ireland - Activelle low 0.5mg/0.1mg film-coated tablets Italy - Activelle® 0,5 mg/0,1 mg compresse film-rivestite Latvia - Noviana 0,5 mg/0,1 mg apvalkotās tabletes Lithuania - Activelle 0,5 mg / 0,1 mg plėvele dengtos tabletės Luxembourg - Activelle minor comprimés pelliculés The Netherlands - Activelle filmomhulde tabletten Norway - Noviana 0,5 mg/0,1 mg tablett filmdrasjert Portugal - 0,5mg Estradiol + 0.1 mg Acetato de Noretisterona Comprimidos revestidos por película Romania – Noviana comprimate filmate Slovenia - Noviana™ filmsko obložene tablete Slovakia - Noviana filmom obalené tablety Spain - Activelle 0,5 mg/ 0,1 mg comprimidos recubiertos de película Sweden - Activelle 0,5 mg/0,1 mg filmdragerade tabletter United Kingdom - Noviana film-coated tablets
Francija - Activelle 0, 5 mg/ 0, 1 mg comprimé pelliculé Nemčija - Noviana Madžarska - Noviana filmtabletta Islandija - Activelle® low 0. 5 mg/ 0. 1 mg tablets filmuhúðaðar töflur Irska - Activelle low 0. 5mg/ 0. 1mg film- coated tablets Italija - Activelle® 0, 5 mg/ 0, 1 mg compresse film- rivestite Latvija - Noviana 0, 5 mg/ 0, 1 mg apvalkotās tabletes Litva - Activelle 0, 5 mg / 0, 1 mg plėvele dengtos tabletės Luksemburg - Activelle minor comprimés pelliculés Nizozemska - Activelle filmomhulde tabletten Norveška - Noviana 0, 5 mg/ 0, 1 mg tablett filmdrasjert Portugalska - 0, 5mg Estradiol + 0. 1 mg Acetato de Noretisterona Comprimidos revestidos por película
37 This leaflet was last approved in
Navodilo je bilo odobreno:
Detailed information on this medicine is available on the web site of {MA/Agency}[PIQ-QRD3]
Podrobne informacije o zdravilu so objavljene na spletni strani {Ime države članice/ Agencije}
USER INSTRUCTIONS
36 NAVODILO ZA UPORABNICO
Set the day reminder Turn the inner disc to set the day of the week opposite the little plastic tab.
Obrnite notranjo ploščico tako, da bo dan v tednu nastavljen ob malo plastično zaporo.
Move the dial every day On the next day simply move the transparent dial clockwise one space as indicated by the arrow.
Vsak dan zavrtite kazalno ploščico Naslednji dan preprosto premaknite prozorno kazalno ploščico v smeri urnega kazalca za en predalček, kot kaže puščica.
London, 12 September 2008 EMEA/ CHMP/ 496102/ 2008
London, 12. september 2008 EMEA/ CHMP/ 496122/ 2008
OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Activelle and associated names
MNENJE V ZVEZI Z NAPOTITVIJO V SKLADU S ČLENOM 29( 4) 1 ZA ZDRAVILO Activelle in povezana imena
International Non-Proprietary Name (INN):
Mednarodno nelastniško ime (INN):
Estradiol and norethisterone acetate
Estradiol in noretisteron acetat
Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets is a continuous combined hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause.
Zdravilo Activelle in povezana imena, estradiol 0, 5 mg in noretisteron acetat, 0, 1 mg, filmsko obložene tablete, se uporablja za kontinuirano kombinirano hormonsko nadomestno zdravljenje (HNZ) simptomov pomanjkanja estrogena pri ženskah več kot eno leto po menopavzi.
Novo Nordisk A/ S submitted applications for mutual recognition of Activelle and associated names, estradiol 0.5mg and norethisterone acetate 0.1 mg film-coated tablets on the basis of the marketing authorisation granted by Sweden on 3 August 2007.
Družba Novo Nordisk A/ S je predložila vloge za medsebojno priznavanje zdravila Activelle in povezana imena, estradiol, 0, 5 mg, ter noretisteron acetat, 0, 1 mg, filmsko obložene tablete, na podlagi dovoljenja za promet z zdravilom, ki ga je odobrila Švedska dne 3. avgusta 2007.
This refers to endometrial safety of Activelle 0.5 mg/ 0.1 mg, which had been insufficiently demonstrated according to the CHMP guideline for HRT products (EMEA/ CHMP/ 021/ 97 rev 1) and this was considered to be of serious public health concern.
1) ni bila zadostno dokazana, kar predstavlja resen zadržek v zvezi z javnim zdravjem.
The arbitration procedure started on 19 March 2008 with the adoption of a list of questions.
Poročevalec je bil dr.