natgillin/translations-raw huggingface dataset:
N = number of patients, which are presented at baseline, Week 12, and Week 52 Q2W = every 2 weeks *Patients were administered ustekinumab in the induction phase and continued on ustekinumab in the maintenance phase **Patients were administered Kyntheum 210 mg every 2 weeks in the induction phase and re-randomised to Kyntheum 210 mg every 2 weeks in the maintenance phase NRI= Non-responder imputation
Q2W = vsaka 2 tedna * Bolniki so prejemali ustekinumab v indukcijski fazi in nadaljevali prejemanje ustekinumaba v vzdrževalni fazi.
Kyntheum is a solution for injection that is a clear to slightly pearly, colourless to slightly yellow liquid, with no particles.
Zdravilo Kyntheum je bistra do rahlo biserna, brezbarvna do rahlo rumenkasta raztopina za injiciranje brez delcev.
The grey needle cap on the pre-filled syringe should not be removed while allowing to reach room temperature.
Med čakanjem, da napolnjena injekcijska brizga doseže sobno temperaturo, ne odstranite sivega pokrovčka igle.
Please read all the instructions before using the Kyntheum pre-filled syringe.
Pred uporabo z zdravilom Kyntheum napolnjene injekcijske brizge preberite vsa navodila.
Used syringe barrel
Uporabljeno ohišje brizge
Impact of weight on pharmacokinetics
Farmakokinetično/farmakodinamično razmerje
Comprehensive instructions for administration are given in the package leaflet.
V navodilu za uporabo so na voljo podrobna navodila za dajanje zdravila.
If any of these side effects becomes severe, tell your doctor, nurse, or pharmacist.
Če kateri koli neželeni učinek postane resen, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Kyntheum is a clear to slightly opalescent, colourless to slightly yellow solution, free from particles.
Zdravilo Kyntheum je bistra do rahlo opalescentna, brezbarvna do rahlo rumenkasta raztopina brez delcev.
B. Check the Kyntheum pre-filled syringe
B. Preverite z zdravilom Kyntheum napolnjeno injekcijsko brizgo.
Grab the syringe barrel to remove the syringe from the tray.
Brizgo primite za ohišje in jo vzemite s pladnja.
NA
Bat
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
• feeling sick
Očesne bolezni
In moderate to severe plaque psoriasis patients following a single subcutaneous administration of Kyntheum at 210 mg, the mean maximum serum concentration (Cmax) was 13.4 mcg/ml (standard deviation [SD] = 7.29 mcg/ml).
(Cmaks) 13,4 mcg/ml (standardno odstopanje [SD] = 7,29 mcg/ml).
Renal or hepatic impairment
Okvara ledvic ali jeter
• Do not shake.
• Ne zamrzujte.
Syringe barrel
Orofaringealna bolečina
Diarrhoea Nausea
Bolezni prebavil
• tiredness
• driska,
Do not place your finger on the plunger while inserting the needle.
Ne položite prstov na bat med vstavljanjem igle.
• cotton ball or gauze pad
• kosem vate ali zloženec iz gaze,
Step 4: Finishing up J. Throw away the used syringe
J. Zavrzite uporabljeno brizgo.
n-completed Week 52
N = število bolnikov v izhodišču, 12. teden in 52. teden
• Do not freeze.
• Ne stresajte.
Talk to your doctor, pharmacist, or nurse before using Kyntheum:
Pred začetkom uporabe zdravila Kyntheum se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Using your Kyntheum pre-filled syringe
Uporaba z zdravilom Kyntheum napolnjene injekcijske brizge
• diarrhoea
• utrujenost,
Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg bodyweight l t o r
Vsako za bolnika specifično pakiranje vsebuje zadostno količino vial za odmerjanje 1 x 1012 gk/kg telesne mase bolnika.
3 x 10¹² gc/ml Solution for injection
3 x 10¹² gk/ml raztopina za injiciranje intramuskularna uporaba viala (steklena) 1 ml
Immediate Packaging
Vsebina Velikost pakiranja
1 ml
o č
Intramuscular use vial (glass)
Pot uporabe Stična ovojnina
This summary was last updated in 08-2010.
Povzetek je bil nazadnje posodobljen 08-2010.
The studies lasted between six weeks and 12 months.
Študije so trajale od šest tednov do 12 mesecev.
This can result in serious vision loss and even blindness.
Posledica tega je lahko resno poslabšanje vida in celo slepota.
The marketing authorisation is valid for an unlimited period.
Dovoljenje za promet z zdravilom velja za nedoločen čas.
Other information about DuoTrav:
Druge informacije o zdravilu DuoTrav:
The European Commission granted a marketing authorisation valid throughout the European Union, for DuoTrav to Alcon Laboratories (UK) Limited on 24 April 2006.
Evropska komisija je dovoljenje za promet z zdravilom DuoTrav, veljavno po vseh Evropski uniji, odobrila podjetju Alcon Laboratories (UK) Limited dne 24. aprila 2006.
This document is a summary of the European public assessment report (EPAR) for DuoTrav.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo DuoTrav.
It contains two active substances: travoprost (40 micrograms per millilitre) and timolol (5 mg/ml).
Vsebuje dve zdravilni učinkovini: travoprost (40 mikrogramov/ml) in timolol (5 mg/ml).
In all of the studies, the main measure of effectiveness was the change in pressure inside the eye measured in ‘millimetres of mercury' (mmHg).
V vseh študijah je bilo glavno merilo učinkovitosti sprememba tlaka v očesu, ki se meri v „milimetrih živega srebra“ (mmHg).
What benefit has DuoTrav shown during the studies?
Kakšne koristi je zdravilo DuoTrav izkazalo med študijami?
What is the risk associated with DuoTrav?
Kakšna tveganja so povezana z zdravilom DuoTrav?
For more information about treatment with DuoTrav, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom DuoTrav preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for DuoTrav.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo DuoTrav, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
DuoTrav can only be obtained with a prescription.
Zdravilo DuoTrav se dobi samo na recept.
The dose of DuoTrav is one drop in the affected eye(s) once a day, in the morning or evening, at the same time every day.
Odmerek zdravila DuoTrav je ena kapljica v prizadeto oko enkrat dnevno, zvečer ali zjutraj ob istem času.
The CHMP decided that DuoTrav's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila DuoTrav večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
If more than one type of eye drop is being used, each one should be given at least five minutes apart.
Če bolnik uporablja več vrst kapljic za oko, je treba zdravila vkapati v razmiku najmanj pet minut.
DuoTrav reduced the pressure inside the eye by about a third in all of the studies (the average reduction was about 8-10 mmHg).
V vseh študijah je zdravilo DuoTrav tlak znotraj očesa znižalo za približno tretjino (povprečno znižanje je bilo približno 8-10 mmHg).
DuoTrav has been studied in five main studies involving a total of 1,482 patients (aged 18 to 91) with open-angle glaucoma or ocular hypertension.
Zdravilo DuoTrav so raziskali v petih glavnih študijah z 1 482 bolniki (starimi od 18 do 91 let) z glavkomom odprtega zakotja ali očesno hipertenzijo.
When the pressure inside the eye rises, it causes damage to the retina (the light sensitive membrane at the back of the eye) and to the optic nerve that sends signals from the eye to the brain.
Ko je tlak znotraj očesa povišan, povzroči poškodbe očesne mrežnice (na svetlobo občutljivih membran v ozadju očesa) in vidnega živca, ki pošilja signale od oči do možganov).
By lowering the pressure, DuoTrav reduces the risk of damaging these structures.
Zdravilo DuoTrav z zniževanjem tlaka zmanjša tveganje za poškodbe teh struktur.
Ocular hypertension is when the pressure in the eye is higher than normal.
Okularna hipertenzija je stanje, pri katerem je tlak v očesu višji od običajnega.
In a patient with glaucoma, the eye pressure is usually higher than 21 mmHg.
Pri bolniku z glavkomom je očesni tlak običajno višji od 21 mmHg.
DuoTrav taken in the evening was as effective as DuoTrav taken in the morning.
Zdravilo DuoTrav, vzeto zvečer, je bilo enako učinkovito kot isto zdravilo, vzeto zjutraj.
The fifth was a 12-month study that compared DuoTrav with eye drops containing a combination of latanoprost (another prostaglandin analogue) and timolol.
Pri peti študiji je šlo za dvanajstmesečno študijo, v kateri so zdravilo DuoTrav primerjali s kapljicami za oči, ki so vsebovale kombinacijo latanoprosta (analoga prostaglandina) in timolola.
DuoTrav contains benzalkonium chloride which is known to discolour soft contact lenses.
Zdravilo DuoTrav vsebuje benzalkonijev klorid, ki lahko razbarva mehke kontaktne leče.
It was as effective as the two medicines given as separate eye drops, and as effective as eye drops containing both latanoprost and timolol.
Bilo je enako učinkovito kot obe zdravili, vzetih skupaj, a v obliki ločenih kapljic za oči, in enako učinkovito kot kapljice za oči, ki vsebujejo kombinacijo latanoprosta in timolola.
The most common side effects with DuoTrav (seen in more than 1 patient in 10) are ocular hyperaemia (increased blood supply to the eye, leading to redness) and eye irritation.
Najpogostejši neželeni učinek zdravila DuoTrav (opažen več kot 1 bolniku od 10) je očesna hiperemija (povečan dotok krvi v oko, kar povzroča pordečitev) in draženje očesa.
It is used in adults with ‘open angle glaucoma' or ‘ocular hypertension' who do not respond sufficiently to eye drops containing beta-blockers or prostaglandin analogues (other medicines used for these conditions).
Uporablja se pri odraslih z glavkomom odprtega zakotja ali okularno hipertenzijo, ki se ne odzivajo dovolj na očesne kapljice, ki vsebujejo zaviralce receptorjev beta ali analoge prostaglandina (drugi vrsti zdravila za zdravljenje teh bolezni).
Therefore, care should be taken by people who wear soft contact lenses.
Zato naj osebe, ki jih nosijo, zdravilo uporabljajo previdno.
DuoTrav should not be used in people who may be hypersensitive (allergic) to travoprost, timolol (and other beta-blockers), or any of the other ingredients.
Zdravila DuoTrav ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) travoprost, timolol (in druge zaviralce receptorjev beta) ali na katero koli drugo sestavino zdravila.
DuoTrav must not be used in people with asthma or severe lung disease, or in people with some heart conditions.
Zdravila DuoTrav se ne sme dajati osebam z astmo, hudim pljučnim obolenjem ali srčnimi obolenji.
DuoTrav is used to reduce the pressure inside the eye.
Zdravilo DuoTrav se uporablja za zniževanje tlaka znotraj očesa.
Three studies compared DuoTrav with travoprost and timolol either given on their own, or together but as separate eye drops.
V treh študijah so zdravilo DuoTrav primerjali s travoprostom in timololom, vzetima bodisi samostojno ali skupaj, vendar kot ločene kapljice za oči.
It must also not be used in people with severe allergic rhinitis (inflammation of the nasal passages caused by an allergy) and corneal dystrophies (disorders that cause clouding of the cornea, the transparent layer in front of the eye).
Ne sme se uporabljati pri ljudeh s hudim alergijskim rinitisom (vnetjem nosne votline, ki ga povzroči alergija) in distrofijo roženice (motnjami, ki povzročajo zamegljenost roženice, prosojnega prednjega dela očesa).
For the full list of all side effects reported with DuoTrav, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila DuoTrav, glejte navodilo za uporabo.
The combination of the two active substances has an additive effect, reducing the pressure inside the eye more than either medicine alone.
Kombinirani učinek obeh zdravilnih učinkovin daje boljše rezultate pri zniževanju tlaka znotraj očesa kot katera koli od obeh učinkovin posamezno.
Travoprost is a prostaglandin analogue (a man-made copy of the natural substance prostaglandin) that works by increasing the drainage of fluid out of the eye. Travoprost on its own has been authorised in the European Union as Travatan since 2001.
Travoprost je analog prostaglandina (umetne kopije naravne snovi prostaglandina), ki deluje tako, da poveča odtok tekočine iz očesa.
What is DuoTrav used for?
Za kaj se zdravilo DuoTrav uporablja?
In open angle glaucoma the high pressure is caused by fluid being unable to drain out of the eye.
Pri glavkomu odprtega zakotja tlak naraste, ker tekočina ne more odtekati iz očesa.
Why has DuoTrav been approved?
Zakaj je bilo zdravilo DuoTrav odobreno?
DuoTrav contains two active substances, travoprost and timolol, which lower the pressure in the eye in different ways.
Zdravilo Duo Trav vsebuje dve zdravilni učinkovini: travoprost in timolol, ki različno znižujeta tlak v očesu.
DuoTrav may cause the iris of the eye to change colour (darken) and the eyelashes to thicken, darken or lengthen.
Zdravilo DuoTrav lahko povzroči spremembo barve (potemnitev) šarenice ter odebelitev, potemnitev ali podaljšanje trepalnic.
What is DuoTrav?
Kaj je zdravilo DuoTrav?
DuoTrav was more effective at reducing the pressure inside the eye than timolol on its own, or travoprost on its own.
Zdravilo DuoTrav je bilo pri zniževanju tlaka znotraj očesa učinkovitejše od timolola ali travoprosta, uporabljenih samostojno.
The full EPAR for DuoTrav is available here.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo DuoTrav je na voljo tukaj.
One study compared DuoTrav taken in the morning with DuoTrav taken in the evening.
V eni študiji so primerjali zdravilo DuoTrav, vzetim zjutraj, z zdravilom, vzetim zvečer.
How is DuoTrav used?
Kako se zdravilo DuoTrav uporablja?
How has DuoTrav been studied?
Kako je bilo zdravilo DuoTrav raziskano?
Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Timolol has been used to treat glaucoma since the 1970's.
Timolol se uporablja za zdravljenje glavkomov že od sedemdesetih let prejšnjega stoletja dalje.
DuoTrav is a clear eye drop solution.
Zdravilo DuoTrav je bistra raztopina za kapljice za oči.
How does DuoTrav work?
Kako zdravilo DuoTrav deluje?
30 sachets + 1 mixing bottle + 30 single-use oral syringes + 1 screw cap with syringe-port capability
30 vrečic + 1 mešalna plastenka + 30 brizg za peroralno odmerjanje za enkratno uporabo + 1 navojna zaporka z nastavkom za namestitev brizge
Oral use sachet (PET/OPA/alu/LDPE)
Stična ovojnina Velikost pakiranja prašek za peroralno suspenzijo peroralna uporaba vrečica (PET/OPA/alu/LDPE)
MA (EU) number (Invented) name Strength
(Izmišljeno) ime Jakost
*** International units.
*** Mednarodne enote.
l Suspension (inactivated)
Suspenzija (inaktivirana)
EU (MA) number
EU (MA) številka Izmišljeno ime
Content Package size
Pakiranje Vsebina Velikost pakiranja
* Tissue culture infectious dose 50%.
* 50% infektivnega odmerka za tkivno kulturo.
** Antibody micro agglutination-lytic reaction.
** Reakcija mikroaglutinacije-lize protiteles.
Pharmaceutic al form
Jakost Farmacevtska oblika
Rabies virus, strain SAD Vnukovo-32
Virus stekline, sev SAD Vnukovo-32
--1 Lyophilisate (live attenuated) Canine parainfluenza type 2 virus, strain CPiV-2 Bio 15
--1 Liofilizat (živi atenuirani) Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
Target specie s
Ciljna živalska vrsta
Packagin g
Karenca
Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa, strain MSLB 1091
Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa, sev MSLB 1091
Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae strain MSLB 1089
Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae, sev MSLB 1089
Route of administrati on
Način uporabe
Leptospira interrogans serogroup Australis serovar Bratislava, strain MSLB 1088
Leptospira interrogans serološka skupina Australis serovar Bratislava, sev MSLB 1088
Leptospira interrogans serogroup Canicola serovar Canicola, strain MSLB 1090
Leptospira interrogans serološka skupina Canicola serovar Canicola, sev MSLB 1090
**Relative Potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep.
**Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
EMEA Number Invented Name
EU številka Izmišljeno ime
Content Package size
Vsebina Velikost pakiranja
Page 2/2
str. 2/2
The final opinion was converted into a Decision by the European Commission on 30 April 2009.
Končno mnenje je bilo spremenjeno v odločbo Evropske komisije dne 30. aprila 2009.
EMEA/681318/2008-EN
EMEA/681318/2008-SL
The assessment report and the opinion were transferred to the European Commission for decision.
Poročilo o oceni in mnenje so v odločanje predali Evropski komisiji.
London, 30 April 2009 EMEA/681319/2008
London, 30. aprila 2009 EMEA/681319/2009
The list of product names concerned is given in the Annex I. The scientific conclusions are provided in the Annex II.
Seznam zadevnih imen izdelkov je naveden v Dodatku I. Znanstveni zaključki so navedeni v Dodatku II.
COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE (CVMP)
ODBOR ZA ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI (CVMP)
(International Non-Proprietary Name (INN): Xylazine, Medetomidine, Detomidine, Romifidine)
(Mednarodno nelastniško ime (INN): ksilazin, medetomidin, detomidin, romifidin)
The veterinarian experienced cardiovascular and central nervous system effects over a period of 3 days.
Pri veterinarju so bili naslednje tri dni prisotni učinki na srčno-žilni in osrednji živčni sistem.
Dr Anja Holm was appointed as Rapporteur and Dr Peter Ekström as Co-Rapporteur.
Kot poročevalka je bila določena dr. Anja Holm, kot soporočevalec pa dr. Peter Ekström.
No new substantial data was provided by any of the responding Marketing Authorisation Holders and therefore the assessment remains based on the data considered in 2006.
Nihče izmed imetnikov dovoljenj za promet z zdravilom ni predložil novih ključnih podatkov, zato ocena še vedno temelji na podatkih, ki so jih upoštevali leta 2006.
The Committee reconfirmed Dr A. Holm as Rapporteur and Dr P. Ekström as Co-Rapporteur for the procedure.
Odbor je ponovno potrdil dr. A. Holm kot poročevalko in dr. P. Ekströma kot soporočevalca v tem postopku.
Alpha2-adrenoreceptor agonists are pharmaceutically active substances that are commonly used to induce effects such as sedation, analgesia and muscle relaxation.
Agonisti adrenergičnih receptorjev alfa2 so farmacevtske zdravilne učinkovine, ki se navadno uporabljajo za sproženje učinkov, kot so sedacija, analgezija in sprostitev mišičja.
The CVMP concluded that, on the basis of the available data, there is at present a potential risk to human health posed by the use of products containing alpha2-adrenoreceptor agonists, and issued a revised opinion on 12 November 2008.
CVMP je na podlagi razpoložljivih podatkov zaključil, da trenutno obstaja morebitno tveganje za človeško zdravje, ki ga predstavlja uporaba zdravil, ki vsebujejo agoniste adrenergičnih receptorjev alfa2, in je dne 12. novembra 2008 izdal spremenjeno mnenje.
Additionally, the CVMP concluded that the need for updating the product literature to reflect the matters above is not urgent.
Poleg tega je CVMP zaključil, da ni potrebna takojšnja posodobitev gradiva zdravil, da bi vključevalo zgoraj navedeno.
Xylazine, detomidine, medetomidine and romifidine are alpha2-adrenoreceptor agonists.
Ksilazin, detomidin, medetomidin in romifidin so agonisti adrenergičnih receptorjev alfa2.
During its December 2006 meeting, the CVMP, in light of the overall data submitted, additional data from the public domain and the scientific discussion within the Committee, adopted by consensus an opinion concerning the 21 veterinary medicinal products as authorised in the Netherlands.
CVMP je na svojem zasedanju decembra 2006 ob upoštevanju vseh predloženih podatkov, dodatnih podatkov iz javne domene in znanstvene razprave znotraj Odbora soglasno sprejel mnenje glede 21 zdravil za uporabo v veterinarski medicini, odobrenih na Nizozemskem.
The basis for the notification was a suspected adverse reaction report received in The Netherlands after a veterinarian accidentally injected himself with the product Sedivet, which contains romifidine as the active ingredient.
Podlaga za obvestilo je bilo poročilo o sumu na neželene učinke, ki je bilo prejeto na Nizozemskem po tem, ko si je veterinar po nesreči vbrizgal zdravilo Sedivet, ki kot zdravilno učinkovino vsebuje romifidin.
OPINION FOLLOWING AN ARTICLE 781 PROCEDURE FOR Veterinary medicinal products containing Alpha2-adrenoreceptor agonists2
MNENJE V ZVEZI S POSTOPKOM V SKLADU S ČLENOM 781 ZA zdravila za uporabo v veterinarski medicini, ki vsebujejo agoniste adrenergičnih receptorjev alfa22
Written responses were received by Marketing Authorisation Holders for 81 of the 108 notified authorisations held by a total of 66 Marketing Authorisation Holders by 16 September 2008.
Imetniki dovoljenj za promet z zdravilom so do 16. septembra 2008 prejeli pisne odgovore za 81 od 108 priglašenih dovoljenj za promet z zdravilom, ki jih je imelo 66 imetnikov dovoljenj za promet z zdravilom.
In accordance with Article 78(3) of Directive 2001/82/EC, as amended, the Committee for Medicinal Products for Veterinary Use (CVMP) is to give its opinion on the conclusions and intended risk management measures presented by the notifying Authority which in this procedure was the Dutch Medicines Evaluation Board.
V skladu s členom 78(3) Direktive 2001/82/ES, kakor je bila spremenjena, mora Odbor za zdravila za uporabo v veterinarski medicini (CVMP) podati svoje mnenje o zaključkih in predlaganih ukrepih obvladovanja tveganj, ki jih je predstavil organ priglasitelj, kar je bil v tem postopku nizozemski odbor za ocenjevanje zdravil.
On 13 September 2006 the procedure was initiated by adoption of a list of questions to be put to the concerned Marketing Authorisation Holders.
Postopek se je začel 13. septembra 2006 s sprejetjem seznama vprašanj za zadevne imetnike dovoljenj za promet z zdravilom.
Member States identified and informed the Agency of the concerned marketing authorisations in their respective territories.
Države članice so identificirale zadevna dovoljenja za promet z zdravilom na svojih ozemljih in o tem obvestile Agencijo.
The concerned Marketing Authorisation Holders were informed accordingly by a letter dated 13 December 2006.
Zadevni imetniki dovoljenj za promet z zdravilom so bili ustrezno obveščeni z dopisom z dne 13. decembra 2006.
Following further communication with the European Commission in years 2007 and 2008 on the opinion and the scope of the procedure, the CVMP in the July 2008 plenary meeting agreed to complete the procedure under Article 78 of Directive 2001/82/EC, as amended, for all marketing authorisations held in the EU for the 21 products containing alpha2-adrenoreceptor agonists initially notified and to revise the initial opinion accordingly.
CVMP se je po nadaljnjem posvetovanju z Evropsko komisijo v letih 2007 in 2008 glede mnenja in obsega postopka na plenarnem zasedanju v juliju 2008 strinjal, da bo zaključil postopek v skladu s členom 78 Direktive 2001/82/ES, kakor je bila spremenjena, za vsa že priglašena dovoljenja za promet z zdravilom v EU za 21 zdravil, ki vsebujejo agoniste adrenergičnih receptorjev alfa2, ter da bo skladno s tem ponovno pregledal prvotno mnenje.
A revised list of questions addressed to the concerned Marketing Authorisation Holders was adopted on 16 July 2008.
Dne 16. julija 2008 je bil sprejet revidiran seznam vprašanj, naslovljen na zadevne imetnike dovoljenj za promet z zdravilom.