natgillin/translations-raw huggingface dataset:
Variability of the main plasma telotristat PK parameters was higher in subjects with severe to moderate renal impairment, with CV% ranging from 53.3% for Cmax to 77.3% for AUC as compared to 45.4% for Cmax and 39.7% for AUC in healthy to mildly impaired subjects, respectively.
77,3 % za vrednost AUC v primerjavi s 45,4 % za vrednost Cmax in 39,7 % za vrednost AUC pri osebah z normalnim delovanjem ledvic oziroma največ blago okvaro ledvic.
• Feeling sick (nausea)
• siljenje na bruhanje (navzea)
In patients treated at 500 mg tid (twice the recommended dose), a median accumulation ratio based on AUC0-4h of 1.095 (minimum, 0.274; maximum, 11.46; n=16; week 24) was observed, with a high inter-subject variability (%CV = 141.8%).
Pri bolnikih, ki so se zdravili z odmerkom 500 mg trikrat na dan (dvakratni priporočeni odmerek), so opazili mediano razmerje kopičenja na osnovi vrednosti AUC0-4ure 1,095 (najmanj 0,274; največ 11,46;
BEAUFOUR IPSEN INDUSTRIE RUE ETHE VIRTON DREUX
RUE ETHE VIRTON
It is also recommended that the MAH should add the ADR “intestinal obstruction” to the section 4.8 of the SmPC and section 4 of PL with the frequency “uncommon”.
Prav tako je priporočljivo, da imetnik dovoljenja za promet z zdravilom v poglavje 4.8 povzetka glavnih značilnosti zdravila (SmPC) in poglavje 4 navodila za uporabo (PIL) doda neželeni učinek “intestinalna obstrukcija” z navedbo pogostnosti “občasni”.
Posology The recommended dose is 250 mg three times daily (tid).
Priporočeni odmerek je 250 mg trikrat na dan.
STATEMENT OF ACTIVE SUBSTANCE(S)
Povprečna vrednost v izhodišču (SD)
This is because this medicine has not been tested in patients with severe liver problems.
Pri bolnikih, ki imajo hude težave z jetri, uporaba tega zdravila namreč ni bila raziskana.
Abdominal distension was reported in 7.1% of patients (5/70) receiving telotristat ethyl 250 mg tid, versus 4.2% in the placebo group (3/71).
O napihnjenosti trebuha so poročali pri 7,1 % bolnikov (5/70), ki so prejemali etiltelotristat v odmerku 250 mg trikrat na dan, v primerjavi s 4,2 % bolnikov v skupini s placebom (3/71).
There was no significant difference between treatment groups for the endpoints of flushing and abdominal pain.
c. p<0,001 Pri opazovanih dogodkih vročinski oblivi in bolečina v trebuhu med skupinama zdravljenja ni bilo pomembne razlike.
Name and address of the manufacturer(s) responsible for batch release
A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov proizvajalca, odgovornega za sproščanje serij BEAUFOUR IPSEN INDUSTRIE
P-glycoprotein (P-gp) and Multi-drug Resistance associated Protein 2 (MRP-2) In vitro telotristat ethyl inhibited P-gp, but its active metabolite did not at the clinically relevant concentrations.
P-glikoprotein (P-gp) in protein, povezan z rezistenco na več učinkovin 2 (MRP-2; “Multi-drug Resistance associated Protein 2”)
This medicine contains the active substance telotristat ethyl.
Kaj je zdravilo Xermelo To zdravilo vsebuje učinkovino etiltelotristat.
Therefore, dose adjustment does not appear necessary in patients with mild, moderate or severe renal impairment; who are not requiring dialysis.
Pri bolnikih z blago, zmerno ali hudo okvaro ledvic, ki ne potrebujejo zdravljenja z dializo, odmerka tako ni treba prilagajati.
Telotristat ethyl 250 mg showed that stool consistency, as measured by Bristol Stool Form Scale, was improved compared with placebo.
Bristol Stool Form, izboljšala v primerjavi s placebom.
Xermelo contains anhydrous lactose as an excipient.
Laktozna intoleranca Zdravilo Xermelo vsebuje brezvodno laktozo kot pomožno snov.
Each tablet contains telotristat etiprate equivalent to 250 mg telotristat ethyl.
Ena tableta vsebuje 250 mg etiltelotristata v obliki telotristatijevega etiprata.
Patients with a mean reduction of at least 1.5 BM per day: 46.7% (telotristat ethyl 250 mg) and 20.0% (placebo);
- bolniki s povprečnim zmanjšanjem za vsaj 1 odvajanje blata na dan: 66,7 % (etiltelotristat v odmerku 250 mg) in 31,1 % (placebo); - bolniki s povprečnim zmanjšanjem za vsaj 1,5 odvajanj blata na dan: 46,7 % (etiltelotristat v odmerku 250 mg) in 20,0 % (placebo); - bolniki s povprečnim zmanjšanjem za vsaj 2 odvajanji blata na dan: 33,3 % (etiltelotristat v odmerku 250 mg) in 4,4 % (placebo).
Uncommon side effects:
Pogosti neželeni učinki:
Peak plasma levels of telotristat ethyl were achieved in 0.53 to 2.00 hours and those of the active metabolite in 1.50 to 3.00 hours after oral administration.
do 2,00 urah, aktivnega presnovka pa v 1,50 do 3,00 urah po peroralni uporabi.
Fertility
Etiltelotristat
Telotristat ethyl 250 mg tid u5-HIAA excretion (mg/24 hours) at baseline
Izločanje u5-HIAA (mg/24 ur) v izhodišču
Bucureşti, 010623
Bucureşti, 010623 Tel: + 40 21 231 27 20
Contents of the pack and other information
Shranjevanje zdravila Xermelo Vsebina pakiranja in dodatne informacije
In patients treated at 250 mg tid, a slight accumulation of telotristat levels was observed with a median accumulation ratio based on AUC0-4h of 1.55 [minimum, 0.25; maximum, 5.00; n=11; week 12], with a high inter-subject variability (%CV = 72%).
Linearnost/nelinearnost Pri bolnikih, ki so se zdravili z odmerkom 250 mg trikrat na dan, so opazili rahlo kopičenje vrednosti telotristata z medianim razmerjem kopičenja na osnovi vrednosti AUC0-4ure 1,55 [najmanj 0,25; največ
What Xermelo is and what it is used for What Xermelo is
Kaj vsebuje navodilo Kaj je zdravilo Xermelo in za kaj ga uporabljamo
Administration of a single dose of 250 mg was well tolerated in subjects with severe to moderate renal impairment.
Osebe s hudo do zmerno okvaro ledvic so enkratni 250-mg odmerek dobro prenašale.
How to store Xermelo
Shranjevanje zdravila Xermelo
Gastrointestinal disorders including nausea, diarrhoea, abdominal pain and vomiting have been reported in healthy subjects taking a single dose of 1,500 mg in a phase 1 study.
Pri zdravih osebah, ki so v študiji 1. faze prejele enkratni odmerek 1.500 mg, so poročali o boleznih prebavil, vključno z navzeo, drisko, bolečino v trebuhu in bruhanjem.
The apparent half-life of telotristat ethyl in normal healthy volunteers following a single 500 mg oral dose 14C-telotristat ethyl was approximately 0.6 hour and that of its active metabolite was 5 hours.
Navidezni razpolovni čas etiltelotristata je pri zdravih prostovoljcih po enkratnem 500-mg peroralnem odmerku
Flatulence was seen in 5.7% of patients (4/70) and 1.4% (1/71) in the telotristat ethyl 250 mg and placebo groups, respectively.
O flatulenci so poročali pri 5,7 % bolnikov (4/70), ki so prejemali etiltelotristat v odmerku 250 mg, in pri 1,4 % (1/71)
This is because this medicine has not been tested in patients with end-stage kidney disease, requiring dialysis.
Pri bolnikih s končno odpovedjo ledvic, ki se morajo zdraviti z dializo, uporaba tega zdravila namreč ni bila raziskana.
Abdominal distension, Constipation, Flatulence
Presnovne in prehranske motnje zmanjšanje apetita
A post-hoc analysis showed that the average number of daily short-acting SSA injections used for rescue therapy over the 12-week DBT period was 0.3 and 0.7 in the telotristat ethyl 250 mg and placebo groups, respectively.
Post-hoc analiza je pokazala, da je povprečno število dnevnih injekcij kratkodelujočega analoga somatostatina, uporabljenih kot rešilno zdravljenje v 12-tedenskem obdobju dvojno slepega
Elevations in ALT >3 × upper limit of normal (ULN) or ALP>2 ULN have been reported in patients receiving therapy with telotristat, most cases being reported at a higher dose (500 mg).
Pri bolnikih, ki so se zdravili s telotristatom, so poročali o zvišanju vrednosti ALT > 3 × zgornja meja normalne vrednosti (ZMN) ali vrednosti alkalne fosfataze > 2 ZMN.
You may feel sick or be sick, have diarrhoea or stomach ache.
Če ste vzeli večji odmerek zdravila Xermelo, kot bi smeli Lahko se pojavi občutek siljenja na bruhanje ali bruhanje, driska ali bolečina v trebuhu.
Tablet core
Drugi CYP
Acid Reducers
• zvišana telesna temperatura
pain in the upper right belly.
rumeno obarvanje kože ali očesnih beločnic, bolečina v zgornjem desnem predelu trebuha.
Number of patients Change averaged over 12 weeks: mean (SD)
Povprečna sprememba v 12 tednih:
A.
(SD)
This is approximately 14 times the human exposure (AUC total) at the maximum recommended human dose (MRHD) of 750 mg/day for the active metabolite LP-778902.
To je približno 14-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
This is approximately 0.4 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
To je približno 0,4-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
This is approximately 21 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
To je približno 21-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
This is approximately 20 times the human exposure (AUC total) at MRHD of 750 mg/day for the active metabolite LP-778902.
To je približno 20-kratna izpostavljenost pri človeku (skupna AUC), pri največjem priporočenem odmerku za človeka 750 mg/dan, za aktivni presnovek LP-778902.
However, 100% compliance has still not been achieved.
Kljub temu 100-odstotna skladnost še vedno ni bila dosežena.
London, 17 June 2008
London, 17. junija 2008
Early dialogue with sponsors
Zgodnji dialog s sponzorji
A decision was taken to extend the pilot phase into 2008.
Sprejeta je bila odločitev za podaljšanje pilotne faze v leto 2008.
I look forward to continued progress and success in 2008.
Že vnaprej se veselim nadaljnjega napredka in uspehov v letu 2008.
Bulgaria and Romania joined the EU on 1 January 2007.
Bolgarija in Romunija sta se pridružili EU 1. januarja 2007.
The levels of activity in these areas increased again in 2007 (see chapter 2).
Stopnja dejavnosti na teh področjih se je leta 2007 znova zvišala (glej poglavje 2).
Vaccination is seen as an important method of control.
Cepljenje se šteje za pomembno nadzorno metodo.
System or process (Status in 2006)
Sistem ali postopek (stanje v letu 2006)
Workshops, conferences, training
Delavnice, konference, usposabljanje
Following this meeting, it was concluded that joint meetings would be held at least once a year, and that representatives from each group would attend meetings of the other group.
Po tem sestanku je bila sprejeta odločitev, da bo skupni sestanek vsaj enkrat na leto in da se bodo predstavniki iz vsake skupine udeleževali sestankov druge skupine.
These systems are evolving in line with communicated requirements.
Ti sistemi se razvijajo v skladu s sporočenimi zahtevami.
2.5 Parallel distribution
2.5 Vzporedna distribucija
Communication on safety issues between all stakeholders is also considered a high priority.
Visoko prednost ima tudi obveščanje o varnostnih vprašanjih med vsemi zainteresiranimi stranmi.
In summary, 2007 was a very productive year with intense activity in many areas, as you will note when you read the detail of this annual report.
Če povzamemo, je bilo leto 2007 zelo plodno leto z intenzivnim delovanjem na številnih področjih, kar boste spoznali, ko boste podrobneje prebrali to letno poročilo.
• We assure continual improvement of our processes and procedures, in accordance with recognised quality standards.
• Zagotavljamo nenehne izboljšave naših procesov in postopkov v skladu s priznanimi standardi kakovosti.
Resource planning in the network
Načrtovanje sredstev v mreži
Information about medicines in all EU languages
Informacije o zdravilih v vseh jezikih EU
As in previous years, the Agency and the Scientific Advice Working Party (SAWP) once again shortened the average time required for the delivery of scientific advice.
Kot v preteklih letih sta Agencija in delovna skupina za znanstveno svetovanje (SAWP) znova skrajšali povprečen čas, ki je potreben za zagotovitev znanstvenega svetovanja.
A series of conclusions were reached that will assist decisionmakers in the relevant organisations.
Sprejetih je bilo vrsto sklepov, ki bodo pomagali nosilcem odločanja v ustreznih organizacijah.
I succeeded Professor Hannes Wahlroos, who had so successfully chaired the Management Board for the previous three years.
Nasledil sem profesorja Hannesa Wahlroosa, ki je zadnja tri leta tako uspešno predsedoval upravnemu odboru.
The majority of EU telematics systems were in use at the beginning of 2007.
Večina telematskih sistemov EU se je uporabljala na začetku leta 2007.
Safety of medicines included in 7th Framework Programme
Varnost zdravil, vključenih v 7. okvirni program
Thirty-six procedures were finalised.
Končanih je bilo 36 postopkov.
Efforts to provide product-related information in all EU languages continued throughout 2007.
Prizadevanja za zagotovitev informacij, povezanih z izdelki, v vseh jezikih EU so se nadaljevala skozi vse leto 2007.
Paediatric Committee fully operational
Odbor za pediatrijo v celoti deluje
This was the first medicine for which an accelerated-assessment procedure was concluded successfully.
To je bilo prvo zdravilo, za katero je bil uspešno dokončan postopek za pospešeno vrednotenje.
It was also the first medicine submitted by a company benefiting from incentives for SMEs.
To je bilo tudi prvo zdravilo, ki ga je predložilo podjetje, ki uporablja spodbude za MSP;
Action plan for European Surveillance Strategy
Akcijski načrt za evropsko strategijo nadzorovanja
The number of withdrawn applications - 19 - was the lowest in the past seven years.
Število umaknjenih vlog - 19 - je bilo najnižje v zadnjih sedmih letih.
These proposals require contributions from both the Agency and national competent authorities.
Ti predlogi zahtevajo prispevek Agencije in nacionalnih pristojnih organov.
• We are strongly committed to public and animal health.
• Močno smo zavezani zdravju ljudi in živali.
Good progress on implementing rules on access to documents
Dober napredek pri izvajanju pravil o dostopu do dokumentov
Work on this has barely started, as guidelines fundamental to the determination of the scope and functionality of the proposed system are not yet available in final form.
Delo pri tem sistemu se je komaj začelo, saj smernice, ki so temelj določanja obsega in funkcionalnosti predlaganega sistema, še niso na voljo v končni obliki.
The Agency also contributed to the availability of a number of new medicines on the market, including new chemical entities and similar biological and generic medicines.
Agencija je prispevala tudi k dostopnosti številnih novih zdravil na trgu, vključno z novimi kemijskimi entitetami ter podobnimi biološkimi in generičnimi zdravili.
Further development of interaction with healthcare professionals, patients and consumers
Nadaljnji razvoj sodelovanja z zdravstvenim osebjem, bolniki in potrošniki
It is a great honour to be appointed to this post and I look forward to working with the members and all partners to advance the important work we undertake on behalf of citizens.
V veliko čast mi je, da sem bil imenovan na to mesto, in zelo se veselim, da bomo s člani in vsemi partnerji nadaljevali pomembno delo, ki ga opravljamo v imenu državljanov.
In addition, feedback from the Member States indicated good quality overall of the translations provided by the pharmaceutical industry.
Poleg tega so povratne informacije držav članice kazale na splošno dobro kakovost prevodov, ki jih je zagotovila farmacevtska industrija.
In collaboration with IFAH-Global, the EMEA hosted a Global Animal Health Conference on 15-16 November 2007.
V sodelovanju z organizacijo IFAH-Global je agencija EMEA gostila konferenco o globalnem zdravju živali, ki je bila 15. in 16. novembra 2007.
1.5 Transparency, communication and provision of information
1.5 Preglednost, obveščanje in zagotavljanje informacij
The first joint meeting with patients and healthcare professionals was held on 1 June 2007.
Prvi skupni sestanek z bolniki in zdravstvenim osebjem je bil 1. junija 2007.
• We value the contribution of our partners and stakeholders to our work.
• Spoštujemo prispevek naših partnerjev in zainteresiranih strani pri našem delu.
Twenty-nine internal and external recruitment procedures were carried out.
Izvedenih je bilo 29 notranjih in zunanjih postopkov za zaposlovanje.
In addition, the EMEA systematically updated EPAR summaries relating to major variations.
Poleg tega je agencija EMEA sistematično posodabljala povzetke EPAR, ki se nanašajo na večje spremembe.
The EMEA had adopted a decision on 4 of the 10 opinions by the end of 2007.
EMEA je do konca leta 2007 sprejela sklepe o štirih od desetih mnenj.
They were transmitted to the European Commission for approval.
Vpisa sta bila poslana v odobritev Evropski komisiji.
Sixty-seven percent of the Agency's revenue came from fee income.
67 % prihodkov Agencije so pomenili prihodki od pristojbin.
At this stage, there is no suggestion that there is a general trend for decreasing activity in this area, but the level of activity will continue to be monitored.
Za zdaj nič ne kaže na splošne smernice zmanjševanja dejavnosti na tem področju, vendar pa bomo stopnjo dejavnosti spremljali še naprej.
1 PRIORITIES IN 2007
1 PREDNOSTNE NALOGE V LETU 2007
Three of the referrals were made under Article 33 and 3 were made under Article 35 of Directive 2001/82/EC.
Tri napotitve so bile izvedene v skladu s členom 33, tri pa v skladu s členom 35 Direktive 2001/82/ES.
Improving the safety of medicines for human and veterinary use was once again one of the Agency's top priorities.
Izboljšanje varnosti zdravil za uporabo v humani in veterinarski medicini je bila znova ena od najpomembnejših nalog Agencije.
In 2007, the Agency's activities in relation to transparency and communication concentrated on consolidating existing activities.
V letu 2007 so se dejavnosti Agencije v zvezi s preglednostjo in obveščanjem osredotočale na krepitev sedanjih dejavnosti.
Seven meetings were held in total.
Skupno je imel sedem sestankov.
The Agency strengthened its internal handling of requests for access to documents.
Agencija je okrepila notranjo obravnavo zahtev za dostop do dokumentov.
The EMEA provided guidance and training for SMEs.
Agencija EMEA je zagotavljala smernice in usposabljanje za MSP.
EudraVigilance Veterinary became the main reporting tool used by national competent authorities.
EudraVigilance za veterinarstvo je postal glavno orodje za poročanje, ki ga uporabljajo nacionalni pristojni organi.
1.3 Stimulation of innovation
1.3 Spodbujanje inovacij
Time required for centralised procedure remains low
Čas, ki je potreben za centralizirani postopek, ostaja kratek
A new referral procedure - the procedure following Article 107(2) of Directive 2001/83/EC as amended - was used for the first time in 2007.
Novi postopek napotitve - postopek v skladu s členom 107(2) Direktive 2001/83/ES, kakor je bila spremenjena - je bil prvič uporabljen v letu 2007.
Contra-indications, warnings and precautions for use
Kontraindikacije, opozorila in previdnostni ukrepi za uporabo
SME Office: supporting innovation among Europe's SMEs
Urad za MSP: podpora inovacijam pri evropskih MSP
In addition to preliminary specification work for the next major upgrade, technical upgrades were implemented on the system.
Poleg predhodnega načrtovanja za naslednjo večjo nadgradnjo so bile v sistemu izvedene tehnične nadgradnje.
Concept of risk-management plans firmly established
Zasnova načrta za obvladovanje tveganja je trdno določena
3.1 Scientific advice Level of activity in relation to scientific advice lower than expected
3.1 Znanstveno svetovanje Stopnja dejavnosti v zvezi z znanstvenim svetovanjem nižja od pričakovane
I would like to thank the members of all the scientific committees and working parties for their hard work, and also to thank the staff of the European Commission for their ongoing support.
Zahvalil bi se še vsem članom znanstvenih odborov in delovnih skupin za njihovo trdo delo ter tudi osebju Evropske komisije za njegovo nenehno podporo.
The EMEA experienced yet another year of increases in all of its areas of activity.
Za agencijo EMEA je bilo to še eno leto porasta na vseh področjih njene dejavnosti.
Two good laboratory practice (GLP) (non-clinical) inspections were carried out.
Izvedena sta bila dva inšpekcijska pregleda dobre laboratorijske prakse (neklinična).
4.3 Sampling and testing
4.3 Vzorčenje in preskušanje
2007 was the fifth year of implementation of the EU telematics projects by the Agency.
Leto 2007 je bilo peto leto, odkar Agencija izvaja telematske projekte EU.
5 EU TELEMATICS STRATEGY
5 TELEMATSKA STRATEGIJA EU
• involves representatives of patients, healthcare professionals and other stakeholders in its work, to facilitate dialogue on issues of common interest;
• v svoje delo vključuje predstavnike bolnikov, zdravstvenih strokovnjakov in drugih zainteresiranih strani, da olajša dialog o temah, ki so v skupnem interesu;
• We promote the well-being, motivation and ongoing professional development of every member of the Agency.
• Spodbujamo dobrobit, motivacijo in nenehno strokovno izpopolnjevanje vsakega člana Agencije.
The EMEA reviewed 92% of the risk-management plans submitted as part of new applications.
EMEA je pregledala 92 % načrtov za obvladovanje tveganja, ki so bili predloženi kot del nove vloge.
EU enlargement
Širitev EU
The Agency received entirely new responsibilities with the entry into force of Regulation (EC) No 1901/2006 on medicinal products for paediatric use (the Paediatric Regulation) on 26 January 2007.
Agencija je dobila popolnoma nove odgovornosti, ko je začela veljati Uredba (ES) št. 1901/2006 o zdravilih za pediatrično uporabo (Uredba o pediatriji) 26. januarja 2007.
This increase from 183 days in 2006 arose due to fewer accelerated procedures being completed in 2007.
To povečanje glede na 183 dni v letu 2006 je nastalo zaradi manjšega števila končanih postopkov pospešenega vrednotenja v letu 2007.
This plan now gives the required predictability to future development of EVV that is necessary for national competent authorities to commit the necessary resources to ensure its full and timely implementation.
Ta načrt zdaj daje potrebno predvidljivost prihodnjemu razvoju EVV, ki je potrebna, da lahko nacionalni pristojni organi dodelijo potrebna sredstva za zagotovitev njegovega popolnega in pravočasnega izvajanja.
Inspections agencies that are not part of the national medicines agencies were added into the EudraNet.
Agencije za inšpekcijske preglede, ki niso del nacionalnih agencij za zdravila, so bile dodane v omrežje EudraNet.
The EMEA also supported the Commission in its work to develop the new Regulation on Advanced Therapies, which was published in December 2007 and which will usher in further new responsibilities for the Agency in 2008.
EMEA je tudi podpirala Komisijo pri njenem delu za razvoj nove Uredbe o naprednih terapijah, ki je bila objavljena decembra 2007 in ki uvaja nove odgovornosti za Agencijo v letu 2008.
EudraPharm was updated in 2007.
Sistem EudraPharm je bil posodobljen v letu 2007.
Sponsors may request advice on whether their product can be classed as a medicinal product, thus being eligible for EMEA procedures.
Sponzorji lahko zaprosijo za nasvet, ali je njihove izdelke mogoče opredeliti kot medicinske izdelke, da tako postanejo upravičenci za postopke agencije EMEA.
Six of these were class-1 recalls, compared with 2 during all of 2006.
Šest od teh umikov je bilo 1. razreda v primerjavi z dvema v vsem letu 2006.
In 2007, the Agency received 7 requests for scientific advice (16 were forecast).
V letu 2007 je Agencija prejela sedem zahtevkov za znanstveno svetovanje (pričakovanih jih je bilo 16).
As of December 2007, however, no referrals regarding herbal medicines had been received.
Vendar pa od decembra 2007 ni bila prejeta nobena napotitev v zvezi z zdravili rastlinskega izvora.
INTRODUCTION BY THE EXECUTIVE DIRECTOR
UVOD IZVRŠNEGA DIREKTORJA
It is believed this results from, among other factors, the Agency's efforts to promote awareness of expedited reporting.
Menimo, da je to med drugim posledica prizadevanj Agencije, da spodbuja zavest o pospešenem poročanju.