natgillin/translations-raw huggingface dataset:
Generalised Anxiety Disorder: Pregabalin Pfizer is used to treat Generalised Anxiety Disorder (GAD).
Generalizirana anksiozna motnja: Zdravilo Pregabalin Pfizer se uporablja za zdravljenje generalizirane anksiozne motnje (GAD - Generalised Anxiety Disorder).
Pregabalin Pfizer may be taken with oral contraceptives.
Zdravilo Pregabalin Pfizer lahko jemljete s peroralnimi kontraceptivi.
Pregabalin Pfizer is for oral use only.
Zdravilo Pregabalin Pfizer je samo za peroralno uporabo.
• There have been reports of convulsions when taking Pregabalin Pfizer or shortly after stopping Pregabalin Pfizer.
• Med jemanjem zdravila Pregabalin Pfizer ali kmalu po prenehanju jemanja so poročali o primerih krčev.
Pregabalin Pfizer 75 mg, 100 mg, 200 mg, 225 mg, 300 mg hard capsules
Pregabalin Pfizer 75 mg, 100 mg, 200 mg, 225 mg, 300 mg trde kapsule
If you forget to take Pregabalin Pfizer
Če ste pozabili vzeti zdravilo Pregabalin Pfizer
The dose range is 150 to 600 mg per day given in either two or three divided doses.
Razpon odmerjanja je od 150 do 600 mg na dan v dveh ali treh deljenih odmerkih.
There have also been postmarketing reports of loss of consciousness, confusion and mental impairment.
V obdobju trženja so poročali tudi o izgubi zavesti,
LABELLING AND PACKAGING LEAFLET
OZNAČEVANJE IN NAVODILO ZA UPORABO
Pregabalin Pfizer 25 mg hard capsules Pregabalin Pfizer 50 mg hard capsules Pregabalin Pfizer 75 mg hard capsules Pregabalin Pfizer 100 mg hard capsules Pregabalin Pfizer 150 mg hard capsules Pregabalin Pfizer 200 mg hard capsules Pregabalin Pfizer 225 mg hard capsules Pregabalin Pfizer 300 mg hard capsules
Pregabalin Pfizer 25 mg trde kapsule Pregabalin Pfizer 50 mg trde kapsule Pregabalin Pfizer 75 mg trde kapsule Pregabalin Pfizer 100 mg trde kapsule Pregabalin Pfizer 150 mg trde kapsule Pregabalin Pfizer 200 mg trde kapsule Pregabalin Pfizer 225 mg trde kapsule Pregabalin Pfizer 300 mg trde kapsule
What you need to know before you take Pregabalin Pfizer Do not take Pregabalin Pfizer:
Kaj morate vedeti, preden boste vzeli zdravilo Pregabalin Pfizer
Do not stop taking Pregabalin Pfizer unless your doctor tells you to.
Če ste prenehali jemati zdravilo Pregabalin Pfizer Ne prenehajte jemati zdravila Pregabalin Pfizer, razen če vam to naroči zdravnik.
What Pregabalin Pfizer looks like and contents of the pack 25 mg capsules
Izgled zdravila Pregabalin Pfizer in vsebina pakiranja 25 mg kapsule
After stopping long and short-term Pregabalin Pfizer treatment, you need to know that you may experience certain side effects.
Po koncu dolgoročnega ali kratkoročnega zdravljenja z zdravilom Pregabalin Pfizer se lahko pri vas pojavijo določeni neželeni učinki.
• Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
• motnje pozornosti, nerodnost, okvara spomina, izguba spomina, tresenje, težave pri govorjenju, mravljinčenje, otrplost, sedacija, stanje podobno globokemu spanju (letargija), nespečnost, utrujenost, nenormalno počutje
6.6 Special precautions for disposal and other handling No special requirements for disposal.
Ni posebnih zahtev za odstranjevanje.
Generalised anxiety disorder Pregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Zdravilo Pregabalin Pfizer je indicirano za zdravljenje generalizirane anksiozne motnje (GADGeneralised Anxiety Disorder) pri odraslih.
What Pregabalin Pfizer is and what it is used for Pregabalin Pfizer belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Zdravilo Pregabalin Pfizer sodi med zdravila, ki se uporabljajo za zdravljenje epilepsije, nevropatske bolečine in generalizirane anksiozne motnje pri odraslih.
PHARMACEUTICAL FORM Hard capsules
trde kapsule
6.1 List of excipients Pregabalin Pfizer 25 mg, 50 mg, 150 mg hard capsules
Pregabalin Pfizer 25 mg, 50 mg, 150 mg trde kapsule
Pregabalin Pfizer may produce dizziness, sleepiness and decreased concentration.
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Pregabalin Pfizer lahko povzroči omotico, zaspanost in poslabša sposobnost koncentracije.
How to take Pregabalin Pfizer
Kako jemati zdravilo Pregabalin Pfizer
Pregabalin Pfizer 150 mg hard capsules Each hard capsule also contains 16.50 mg lactose monohydrate.
Pregabalin Pfizer 150 mg trde kapsule Ena trda kapsula vsebuje tudi 16,50 mg laktoze monohidrata.
Pregabalin Pfizer 300 mg hard capsules Each hard capsule also contains 33 mg lactose monohydrate.
Pregabalin Pfizer 300 mg trde kapsule Ena trda kapsula vsebuje tudi 33 mg laktoze monohidrata.
Pregabalin Pfizer 150 mg hard capsules EU/1/14/916/024-029
Pregabalin Pfizer 150 mg trde kapsule EU/1/14/916/024-029
Pregabalin Pfizer 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Pregabalin Pfizer 225 mg trde kapsule Ena trda kapsula vsebuje 225 mg pregabalina.
Pregabalin Pfizer 225 mg hard capsules EU/1/14/916/034-037
Pregabalin Pfizer 225 mg trde kapsule EU/1/14/916/034-037
Pregabalin Pfizer 225 mg hard capsules Each hard capsule also contains 24.75 mg lactose monohydrate.
Pregabalin Pfizer 225 mg trde kapsule Ena trda kapsula vsebuje tudi 24,75 mg laktoze monohidrata.
Pregabalin Pfizer 200 mg hard capsules Each hard capsule also contains 22 mg lactose monohydrate.
Pregabalin Pfizer 200 mg trde kapsule Ena trda kapsula vsebuje tudi 22 mg laktoze monohidrata.
Pregabalin Pfizer 75 mg hard capsules Each hard capsule also contains 8.25 mg lactose monohydrate.
Pregabalin Pfizer 75 mg trde kapsule Ena trda kapsula vsebuje tudi 8,25 mg laktoze monohidrata.
• Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attack, apathy, aggression, elevated mood,
• spremembe v dojemanju sebe, nemir, depresija, tesnoba, nihanje razpoloženja, težave pri iskanju besed, halucinacije, nenormalne sanje, napad panike, otopelost, agresija, vzneseno razpoloženje, poslabšanje mentalnih sposobnosti, težave pri razmišljanju, zvečanje zanimanja za spolnost, težave pri spolnosti (vključno z doseganjem vrhunca), zapoznela ejakulacija
Pregabalin Pfizer 300 mg hard capsules EU/1/14/916/038-043
Pregabalin Pfizer 300 mg trde kapsule EU/1/14/916/038-043
How to store Pregabalin Pfizer
Shranjevanje zdravila Pregabalin Pfizer
Pregabalin Pfizer 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Pregabalin Pfizer 75 mg trde kapsule Ena trda kapsula vsebuje 75 mg pregabalina.
Pregabalin Pfizer 200 mg hard capsules EU/1/14/916/030-033
Pregabalin Pfizer 200 mg trde kapsule EU/1/14/916/030-033
Pregabalin Pfizer 100 mg hard capsules EU/1/14/916/020-023
Pregabalin Pfizer 100 mg trde kapsule EU/1/14/916/020-023
Pregabalin Pfizer 100 mg hard capsules Each hard capsule also contains 11 mg lactose monohydrate.
Pregabalin Pfizer 100 mg trde kapsule Ena trda kapsula vsebuje tudi 11 mg laktoze monohidrata.
Pregabalin Pfizer 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Pregabalin Pfizer 150 mg trde kapsule Ena trda kapsula vsebuje 150 mg pregabalina.
Pregabalin Pfizer 75 mg hard capsules EU/1/14/916/014-019
Pregabalin Pfizer 75 mg trde kapsule EU/1/14/916/014-019
Pregabalin Pfizer 25 mg hard capsules Each hard capsule also contains 35 mg lactose monohydrate.
Pregabalin Pfizer 25 mg trde kapsule Ena trda kapsula vsebuje tudi 35 mg laktoze monohidrata.
Pregabalin Pfizer 50 mg hard capsules EU/1/14/916/008-013
Pregabalin Pfizer 50 mg trde kapsule EU/1/14/916/008-013
Pregabalin Pfizer 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Pregabalin Pfizer 100 mg trde kapsule Ena trda kapsula vsebuje 100 mg pregabalina.
Pregabalin Pfizer 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Pregabalin Pfizer 200 mg trde kapsule Ena trda kapsula vsebuje 200 mg pregabalina.
Pregabalin Pfizer 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Pregabalin Pfizer 300 mg trde kapsule Ena trda kapsula vsebuje 300 mg pregabalina.
Pregabalin Pfizer 225 mg hard capsules Pregabalin
Pregabalin Pfizer 225 mg trde kapsule pregabalin
Pregabalin Pfizer 50 mg hard capsules Each hard capsule also contains 70 mg lactose monohydrate.
Pregabalin Pfizer 50 mg trde kapsule Ena trda kapsula vsebuje tudi 70 mg laktoze monohidrata.
White and orange hard capsules, with “Pfizer” marked on the cap and “PGN 300” on the body.
Belo-oranžne trde kapsule z oznako »Pfizer« na pokrovčku in »PGN 300« na telesu kapsule.
Pregabalin Pfizer 75 mg hard capsules Pregabalin
Pregabalin Pfizer 75 mg trde kapsule pregabalin
Pregabalin Pfizer 25 mg hard capsules EU/1/14/916/001-007
Pregabalin Pfizer 25 mg trde kapsule EU/1/14/916/001-007
Pregabalin Pfizer 200 mg hard capsules Pregabalin
Pregabalin Pfizer 200 mg trde kapsule pregabalin
Pregabalin Pfizer 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Pregabalin Pfizer 50 mg trde kapsule Ena trda kapsula vsebuje 50 mg pregabalina.
Pregabalin Pfizer 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
Pregabalin Pfizer 25 mg trde kapsule Ena trda kapsula vsebuje 25 mg pregabalina.
Neutropaenia
Dojenje
Pregabalin Pfizer 50 mg hard capsules
Pregabalin Pfizer 50 mg trde kapsule
• There have been reports of reduction in brain function (encephalopathy) in some patients taking Pregabalin Pfizer when they have other conditions.
• Pri nekaterih bolnikih, ki jemljejo zdravilo Pregabalin Pfizer in imajo tudi druge težave z zdravjem, so poročali o zmanjšanju možganske funkcije (encefalopatiji).
• There have been reports of kidney failure in some patients when taking Pregabalin Pfizer.
• Pri nekaterih bolnikih, ki so jemali zdravilo Pregabalin Pfizer, so opisani primeri odpovedi ledvic.
Pregabalin Pfizer 25 mg hard capsules
Pregabalin Pfizer 25 mg trde kapsule
Pregabalin Pfizer 100 mg hard capsules Pregabalin
Pregabalin Pfizer 100 mg trde kapsule pregabalin
Printing ink:
masa x
Blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Pretisni omot (14, 56 in 100) in perforirani enoodmerni pretisni omot (100) za 225 mg trde kapsule
Pregabalin Pfizer 300 mg hard capsules Pregabalin
Pregabalin Pfizer 300 mg trde kapsule pregabalin
Carton of blister pack (14, 56 or 100) and perforated unit dose blister pack (100) for 225 mg hard capsules
Škatla s pretisnim omotom (14, 56 in 100) in perforiranim enoodmernim pretisnim omotom (100) za 225 mg trde kapsule
Pregabalin Pfizer 150 mg hard capsules Pregabalin
Pregabalin Pfizer 150 mg trde kapsule pregabalin
Pregabalin Pfizer 50 mg hard capsules Pregabalin
Pregabalin Pfizer 50 mg trde kapsule pregabalin
Pregabalin Pfizer 25 mg hard capsules Pregabalin
Pregabalin Pfizer 25 mg trde kapsule pregabalin
Pregabalin Pfizer 50 mg hard capsules PVC/Aluminium blisters containing 14, 21, 56, 84, or 100 hard capsules.
PVC/aluminijski pretisni omoti s 14, 21, 56, 84 ali 100 trdimi kapsulami.
Carton of blister pack (14, 56, 100, and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Škatla s pretisnim omotom (14, 56, 100 in 112) in perforiranim enoodmernim pretisnim omotom (100) za 75 mg trde kapsule
Psychiatric disorders Common
Redki dezinhibicija
Pregabalin Pfizer 100 mg hard capsules PVC/Aluminium blisters containing 21, 84, or 100 hard capsules.
PVC/aluminijski pretisni omoti z 21, 84 ali 100 trdimi kapsulami.
Blister pack (14, 56, 100 or 112) and perforated unit dose blister pack (100) for 75 mg hard capsules
Pretisni omot (14, 56, 100 in 112) in perforirani enoodmerni pretisni omot (100) za 75 mg trde kapsule
• Sore throat.
• vneto žrelo
It is advised not to drink alcohol while taking Pregabalin Pfizer.
Če jemljete zdravilo Pregabalin Pfizer, odsvetujemo pitje alkohola.
In addition, Pregabalin Pfizer is available in an HDPE bottle containing 200 capsules for the 25 mg, 75 mg, 150 mg and 300 mg strengths.
Poleg tega je zdravilo Pregabalin Pfizer v jakostih 25 mg, 75 mg, 150 mg in 300 mg na voljo v plastenki iz polietilena visoke gostote z 200 kapsulami.
Pregabalin Pfizer 150 mg hard capsules PVC/Aluminium blisters containing 14, 56, 100, or 112 hard capsules.
PVC/aluminijski pretisni omoti s 14, 56, 100 ali 112 trdimi kapsulami.
Some of the objectives of the action plan include:
Nekateri cilji akcijskega načrta so:
The agreement on an option may be needed as early as this autumn.
Sporazum o eni od možnosti je morda potreben že to jesen.
Commissioner John Dalli visited the Agency on 5 March 2010.
Komisar John Dalli je 5. marca 2010 obiskal agencijo.
The discussion is foreseen for the October meeting.
Razprava je predvidena za oktobrsko sejo.
Other members were invited to join.
Drugi člani so bili pozvani, naj se jim pridružijo.
The two-day meeting started on 17 March with a presentation on decision making.
Dvodnevna seja se je začela 17. marca s predstavitvijo o sprejemanju odločitev.
Fourteen of the new posts are requested due to increased workload and/or new activities.
Štirinajst novih delovnih mest se zahteva zaradi večje delovne obremenitve in/ali novih dejavnosti.
to 25 February 2010.
25. februarja 2010.
This provision is in line with reimbursement rules of other EU institutions.
Ta določba je skladna s pravili o nadomestilih drugih institucij EU.
Additional information was provided in a written report.
Dodatne informacije so na voljo v pisnem poročilu.
The report will be sent to the topic coordinators by the end of April.
Poročilo bo tematskim koordinatorjem poslano do konca aprila.
This cooperation was a prerequisite for the successful response to the threat.
To sodelovanje je pogoj za uspešen odziv na nevarnost.
The group plans to meet twice a year.
Skupina načrtuje dva sestanka na leto.
A number of suggestions for future developments in the field were provided.
Podani so bili številni predlogi za prihodnji razvoj dogodkov na tem področju.
The above trends underline the importance of the operation of policies that support small and mediumsized enterprises.
Zgornje težnje poudarjajo pomen delovanja politik, ki podpirajo mala in srednje velika podjetja.
A joint conference organised by the European Commission and the Agency will take place on 30 June 2010.
Skupna konferenca Evropske komisije in agencije bo potekala 30. junija 2010.
All newly requested staff posts are financed through fee revenue.
Vsa na novo zahtevana delovna mesta se financirajo s prihodki od pristojbin.
The Agency's partners and stakeholders will be invited to participate.
Partnerji agencije in zainteresirane strani bodo povabljeni k sodelovanju.
Although the Commission confirmed that the decision had already been taken, the Board called for further debate on this matter.
Čeprav je Komisija potrdila, da je bila odločitev že sprejeta, je Odbor pozval k nadaljnji razpravi o tem vprašanju.
A number of countries chose not to participate in the pilot.
Številne države so se odločile, da ne bodo sodelovale v poskusnem projektu.
New website of the Agency
Nova spletna stran agencije
• collecting information on the uptake of the traditional use registration scheme in Member States;
• zbrati informacije o koriščenju sheme za registracijo tradicionalne uporabe v državah članicah;
The H1N1 pandemic continues to affect Africa, and EU vaccine stock is being exported to affected countries.
Pandemija H1N1 še vedno pretresa Afriko in zaloga cepiva EU se izvaža v prizadete države.
The group will examine in greater detail the requirement put forward by the Court of Auditors.
Skupina bo podrobneje proučila zahtevo Računskega sodišča.
• HMPC presentation.
• Predstavitev HMPC.
• Future revision of the transparency directive, with a view to promoting competitiveness of industry and innovation.
• prihodnjo spremembo direktive o preglednosti, da se spodbuja konkurenčnost industrije in inovacij;
• Performance of the Agency's scientific procedures:
• Izvajanje znanstvenih postopkov agencije:
When available, the options will be presented to the Management Board.
Ko bodo možnosti na voljo, bodo predstavljene upravnemu odboru.
The Board noted that the topic coordinators will continue reflecting on the payment system.
Odbor je omenil, da bodo tematski koordinatorji še naprej razmišljali o sistemu plačil.
The budget represents an increase of €20.7 million (10.5%) over the 2010 budget.
Proračun je za 20,7 milijona EUR (10,5 %) večji od proračuna za leto 2010.
The Agency delivered opinions within legislative timelines and achieved the majority of set targets.
Agencija je predložila mnenja v zakonskih rokih in dosegla večino zastavljenih ciljev.
Members stressed that a very short lead time from identification of the threat to the start of vaccination was only possible due to cooperation of regulators and industry.
Člani so poudarili, da je zelo kratek čas od opredelitve nevarnosti do začetka cepljenja mogoč samo zaradi sodelovanja med regulativnimi organi in industrijo.
• implementation of the e-submissions system across the EU and the future workshop on this topic;
• izvajanjem sistema e-predložitev v EU in prihodnjo delavnico o tej temi;
Information on the use of vaccines in those countries will add to the pool of knowledge on the safety and effectiveness of these vaccines.
Informacije o uporabi cepiv v teh državah bodo razširile vedenje o varnosti in učinkovitosti teh cepiv.
Depending on the outcome, the European Commission and the European Parliament will be informed about a preferred option.
Evropska komisija in Evropski parlament bosta odvisno od izida obveščena o prednostni možnosti.
• Note on the outcome of the selection procedure for patients'/consumers' representatives to participate as observers in the PhVWP.
• Obvestilo o rezultatu izbirnega postopka za predstavnike bolnikov/potrošnikov, ki bodo kot opazovalci sodelovali v skupini PhVWP.
A few deviations occurred, notably in the field of herbal medicinal products.
Bila so nekatera odstopanja, zlasti na področju zdravil rastlinskega izvora.
The budget includes estimated fee revenue of €163 million and a requested Community contribution of €47.1 million, which the Commission representative indicated was beyond the current EU financial perspectives.
Proračun vključuje ocenjene prihodke iz pristojbin v višini 163 milijonov EUR in zahtevan prispevek Skupnosti v višini 47,1 milijona EUR, za katerega je predstavnik Komisije navedel, da je višji od zdajšnjih finančnih obetov EU.
The Board thanked the topic coordinators (Chair, Austria and the Netherlands) for their contribution in preparing these documents.
Odbor se je zahvalil tematskim koordinatorjem (predsedniku, Avstriji in Nizozemski) za njihov prispevek pri pripravi teh dokumentov.
The Board noted that the evaluation of the Agency commissioned by the European Commission and carried out by Ernst & Young has been completed.
Odbor je opozoril, da je ocena agencije, ki jo je naročila Evropska komisija in izvedlo podjetje Ernst & Young, končana.
• Benchmarking of European Medicines Agencies (BEMA).
• primerjalno analizo evropskih agencij za zdravila (BEMA).
The PDB for 2011 totals €218.9 million, in line with the work programme.
PDB za leto 2011 znaša 218,9 milijona EUR in je skladen z delovnim programom.
The MBTC and Heads of Medicines Agencies telematics group will work to ensure optimum collaboration.
MBTC in skupina za telematiko vodij agencij za zdravila si bosta prizadevala za čim boljše sodelovanje.
Preparation for a written procedure on adoption of amending budget No 1/2010
Priprava na pisni postopek za sprejetje spremembe proračuna št. 1/2010
As a consequence, the number of contract agents will decrease by 35 in 2011 compared to 2010.
Zato se bo število pogodbenih uslužbencev leta 2011 v primerjavi z letom 2010 zmanjšalo za 35.
Visit of the Commissioner for Health and Consumer Policy
Obisk komisarja za zdravje in varstvo potrošnikov
In this respect, the Board welcomed the Norwegian model, where the agency has involved universities in producing draft monographs.
Odbor je v zvezi s tem pozdravil norveški model, v okviru katerega je agencija v pripravo osnutkov monografij vključila univerze.
• Completion of the evaluation of the Agency and the upcoming conference on the report; the Board asked to see the report before its publication.
• zaključkom ocene agencije in bližnjo konferenco o poročilu; Odbor je zahteval, naj se mu poročilo predloži, preden bo objavljeno;
A common statement by the Heads of Medicines Agencies could help to communicate with national parliaments and bodies in light of the ongoing debate on national strategies applied during the crisis.
Skupna izjava vodij agencij za zdravila bi lahko olajšala sporazumevanje z nacionalnimi parlamenti in organi glede na zdajšnjo razpravo o nacionalnih strategijah, ki se uporabljajo v krizi.
Mr Dalli stressed that patients' interests are at the heart of his and our work.
Poudaril je, da so interesi bolnikov v središču njegovega in našega dela.
The members will have three weeks to draft an analysis and assessment, which will be submitted to the Management Board for adoption around 20 May 2010.
Člani bodo imeli tri tedne časa za pripravo osnutka analize in ocene, ki ju bodo upravnemu odboru predložili v sprejetje okrog 20. maja 2010.
The proportion of new marketing authorisation applications for human medicines with negative outcomes increased to 33% last year, compared to 20-25% in previous years.
Delež novih vlog za pridobitev dovoljenja za promet z zdravilom za uporabo v humani medicini z negativnim izidom se je lansko leto povečal na 33 % v primerjavi s prejšnjimi leti, ko je znašal 20-25 %.
The amendments clarify, among others, that the procedure does not apply to re-nominations of members/alternates for which the Management Board was already consulted.
Skladno s spremembami je med drugim jasno, da postopek ne velja za vnovična imenovanja članov/nadomestnih članov, o katerih je upravni odbor že izrazil mnenje.
• Visits of Commissioner Dalli to EMA and EFSA.
• obiski komisarja Dallija v agencijah EMA in EFSA;
It was pointed out that the term of office of the current Chair of the Management Board will expire in June.
Opozorjeno je bilo, da se bo mandat zdajšnjemu predsedniku upravnega odbora iztekel junija.
Members considered that the decision should take into account the fact that cells and tissues can be raw materials for medicinal products.
Člani so menili, da bi bilo treba pri odločitvi upoštevati, da so celice in tkiva lahko surovine za zdravila.
The Board asked to accelerate the procedure to enable members to consider candidates in June.
Odbor je zahteval pospešitev postopka, da se članom omogoči, da junija razmišljajo o kandidatih.
• improving the output of the Committee;
• izboljšati učinek Odbora;
Amendments to fees payable to the European Medicines Agency and other measures
Spremembe pristojbin, ki se plačujejo Evropski agenciji za zdravila, in drugih ukrepov
A representative of the European Commission will attend the next meeting to outline details of the recent evaluation of EU agencies and the Commission's response.
Naslednjega sestanka se bo udeležil predstavnik Evropske komisije, ki bo na kratko predstavil podrobnosti nedavne ocene agencij EU in odziv Komisije.
The action plan will now be discussed at the Heads of Medicines Agencies in April.
O akcijskem načrtu bodo aprila razpravljali vodje agencij za zdravila.
It will review the existing governance structures and consider alternative arrangements to optimise the governance of the programme.
Proučil bo zdajšnje strukture vodenja in razmislil o alternativni ureditvi, da bi optimiziral vodenje programa.
• Progress on the pharmaceutical package (legislative proposals on pharmacovigilance, falsified medicines and the proposal on provision of information to patients).
• napredkom pri farmacevtskem paketu (zakonodajnimi predlogi o farmakovigilanci, ponarejenih zdravilih in predlogu za zagotavljanje informacij bolnikom);
The Agency will also start preparing for the implementation of legislation on pharmacovigilance and falsified medicines.
Agencija se bo tudi začela pripravljati na izvajanje zakonodaje o farmakovigilanci in ponarejenih zdravilih.