FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 place Renault 92844 Rueil-Malmaison Cedex
Estonian: 92844 Rueil-Malmaison Cedex
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Estonian: LISA I RAVIMI NIMETUSTE, RAVIMVORMI, TUGEVUSE, MANUSTAMISVIISIDE, MÜÜGILOA HOIDJATE LOETELU LIIKMESRIIKIDES
English: Final height data were not available.
Estonian: Lõplikud andmed kehapikkuse kohta ei ole teada.
English: AstraZeneca AS Hoffsveien 70B, Box 200 Vinderen 0319 Oslo, Norway
Estonian: AstraZeneca AS Hoffsveien 70B, Box 200 Vinderen 0319 Oslo, Norra
English: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo, Finland
Estonian: AstraZeneca Oy Luomanportti 3 FI-02200 Espoo, Soome
English: Mating indices were adversely affected in both dose groups, whilst a reduction in fertility was evident only at the 400 mg/l dose level.
Estonian: Paaritumisnäitajad vähenesid mõlema annuse rühmas, samal ajal kui fertiilsuse vähenemine ilmnes ainult 400 mg/l annuse juures.
English: No data on the potential long-term effects of anastrozole treatment in children are available (see also section 5.3).
Estonian: Anastrosooli ravi võimalike pikaajaliste toimete kohta lastel puuduvad andmed (vt ka lõik 5.3).
English: Arimidex is not indicated for use in children.
Estonian: ARIMIDEX ei ole näidustatud laste raviks.
English: Arimidex is not recommended for use in children due to insufficient data on safety and efficacy (see sections 4.4 and 5.1).
Estonian: ARIMIDEXi ei soovitata kasutada lastel ebapiisavate ohutuse ja efektiivsuse andmete tõttu (vt lõigud 4.4 ja 5.1).
English: LU1 3LU, UK
Estonian: LU1 3LU, Ühendkuningriik
English: Since anastrozole reduces oestradiol levels, Arimidex must not be used in girls with growth hormone deficiency in addition to growth hormone treatment.
Estonian: Kuna anastrosool vähendab östradiooli taset, ei tohi ARIMIDEXi kasutada kasvuhormooni puudulikkusega tütarlastel lisaks ravile kasvuhormooniga.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Arimidex in one or several subsets of the paediatric population in short stature due to growth hormone deficiency (GHD), testotoxicosis, gynaecomastia, and McCune-Albright syndrome.
Estonian: Euroopa Ravimiamet on loobunud nõudest esitada ARIMIDEXi lühiajaliste uuringute tulemused ühe või enama pediaatrilise alarühma kohta, mida iseloomustab kasvuhormooni puudulikkusest (GHD), testotoksikoosist, günekomastiast või McCune'i-Albrighti sündroomist tingitud lühike kasv.
English: Children
Estonian: Lapsed
English: There was no significant difference in growth rate after 12 months of treatment, relative to the growth rate during the 6 months prior to entering the study.
Estonian: Pärast 12-kuulist ravi ei leitud olulist erinevust pikkuskasvus võrreldes pikkuskasvuga kuue kuu jooksul enne uuringusse sisenemist.
English: Luxembourg NV AstraZeneca SA Rue Egide Van Ophem B-1180 Bruxelles
Estonian: Luksemburg NV AstraZeneca SA Rue Egide Van Ophem B-1180 Bruxelles
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
Estonian: NV AstraZeneca SA Egide Van Ophemstraat B-1180 Brussel
English: AstraZeneca Pharmaceuticals AB S-15185 Södertälje Sweden
Estonian: AstraZeneca Pharmaceuticals AB S-15185 Södertälje Rootsi
English: After 3 years anastrozole was found to statistically significantly slow bone maturation in pubertal boys on growth hormone therapy.
Estonian: Pärast 3 aastat kestnud ravi leiti, et anastrosool aeglustab statistiliselt oluliselt luude arengut kasvuhormoonravi saavatel puberteediealistel poisslastel.
English: Testotoxicosis
Estonian: Testotoksikoos
English: Arimidex should not be used in boys with growth hormone deficiency in addition to growth hormone treatment.
Estonian: ARIMIDEXi ei tohi kasutada kasvuhormooni puudulikkusega poisslastel lisaks ravile kasvuhormooniga.
English: An open-label, non-comparative, multi-centre study evaluated 14 male patients (aged 2-9) with familial male-limited precocious puberty, also known as testotoxicosis, treated with combination of Arimidex and bicalutamide.
Estonian: Avatud rühmadega mittevõrdlevas hulgikeskuselises uuringus hinnati 14 meessoost patsienti (vanuses 2-9 aastat) perekondliku meestel avalduva enneaegse puberteediga, mida nimetatakse ka testotoksikoosiks, keda raviti ARIMIDEXi ja bikalutamiidiga.
English: Short stature due to growth hormone deficiency A randomised, double-blind, multi-centre study evaluated 52 pubertal boys (aged 11-16 years inclusive) with GHD treated for 12 to 36 months with Arimidex 1 mg/day or placebo in combination with growth hormone.
Estonian: Kasvuhormooni puudulikkusega seotud lühike kasv Randomiseeritud topeltpimedas hulgikeskuselises uuringus hinnati 52 puberteedieas poisslast (vanuses 11-16 aastat, kaasa arvatud), kes said GHD tõttu 12-36 kuu jooksul ravi kas ARIMIDEXiga annuses 1 mg/päevas või platseebot, kumbagi kombineerituna kasvuhormooniga.
English: Arimidex is not recommended for use in children as safety and efficacy have not been established in this group of patients (see section 5.1).
Estonian: ARIMIDEXi ei soovitata kasutada lastel, kuna selles patsiendirühmas ei ole ohutust ja efektiivsust piisavalt uuritud (vt lõik 5.1).
English: In a fertility study weanling male rats were dosed orally with 50 or 400 mg/l anastrozole via their drinking water for 10 weeks.
Estonian: Fertiilsusuuringus manustati isastele võõrutatud rottidele anastrosooli koos joogiveega annuses 50 või 400 mg/l 10 nädala jooksul.
English: SK 10 2 NA, UK
Estonian: SK 10 2 NA, Ühendkuningriik
English: While the number of children treated was too limited to draw any reliable conclusions on safety, there was an increased fracture rate and a trend towards reduced bone mineral density in the anastrozole arm compared to placebo.
Estonian: Ravi saanud laste hulk oli liiga väike usaldusväärse ohutusalase kokkuvõtte jaoks, kuid anastrosooli ravirühmas ilmnes siiski luumurdude sageduse tõus ja luutiheduse langus võrreldes platseeborühmaga.
English: No statistically significant difference with placebo was observed for the growth related parameters of predicted adult height, height, height SDS, and height velocity.
Estonian: Statistiliselt olulisi erinevusi ei täheldatud kasvuga seotud parameetrites, nagu eeldatav kehapikkus täiskasvanuna, kehapikkus, kehapikkuse standardhälve ja pikkuskasvu kiirus.
English: The Applicant commits to the following:
Estonian: Müügiloa taotleja kohustub
English: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, UK.
Estonian: AstraZeneca UK Limited, 600 Capability Green, Luton, LU1 3LU, Ühendkuningriik
English: 4 Theotokopoulou & Astronafton str 151 25 Maroussi
Estonian: 4 Theotokopoulou & Astronafton str
English: AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCT CHARACTERISTICS FOR ARIMIDEX.
Estonian: TÄIENDUSED ARIMIDEXI RAVIMI OMADUSTE KOKKUVŎTTE OLULISTELE LŎIKUDELE.
English: Efficacy has not been established in the paediatric populations studied (see below).
Estonian: Uuritud pediaatrilistel patsientidel ei ole ARIMIDEXi efektiivsust kindlaks tehtud (vt allpool).
English: Paediatrics
Estonian: Pediaatrilised andmed
English: In the pivotal clinical trial, efficacy was not demonstrated and safety was not established (see section 5.1).
Estonian: Läbiviidud pilootuuringus ei saadud efektiivsust toetavaid andmeid ning ohutusalast teavet (vt 5.1).
English: United Kingdom AstraZeneca UK Limited 600 Capability Green Luton
Estonian: Ühendkuningriik AstraZeneca UK Limited 600 Capability Green
English: ANNEX II AMENDMENT TO SUMMARY OF PRODUCT CHARACTERISTICS
Estonian: LISA II RAVIMI OMADUSTE KOKKUVŎTTE TÄIENDUS
English: Member State Marketing Authorisation Holder Invented Name Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamisviis
English: AstraZeneca UK Limited, Silk Road Business Park Macclesfield, Cheshire,
Estonian: AstraZeneca UK Limited, Silk Road Business Park Macclesfield,
English: Information for patients and healthcare professionals
Estonian: Teave patsientidele ja tervishoiutöötajatele
English: Basis for the recommendations
Estonian: Soovituste alused
English: Member State representatives agree new restrictions and pregnancy prevention programme
Estonian: Liikmesriikide esindajad leppisid kokku uued piirangud ja rasedusennetuskava
English: − a review of ongoing treatment by a specialist at least annually,
Estonian: toimuva ravi läbivaatamine eriarsti poolt vähemalt kord aastas;
English: The review of valproate medicines was initiated on 9 March 2017 at the request of the French medicines regulator ANSM, under Article 31 of Directive 2001/83/EC.
Estonian: Valproaati sisaldavate ravimite läbivaatamine algas 9. märtsil 2017 Prantsusmaa ravimiameti (ANSM) taotlusel kooskõlas direktiivi 2001/83/EÜ artikliga 31.
English: They are marketed under several brand names including: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro and Valprolek.
Estonian: Neid turustatakse mitme raviminimetuse, näiteks järgmiste all: Absenor, Convival Chrono, Convulex, Delepsine, Depakin, Depakine, Depakote, Depamag, Depamide, Deprakine, Diplexil, Dipromal, Epilim, Episenta, Epival, Ergenyl, Espa-Valept, Hexaquin, Kentlim, Leptilan, Micropakine L.P., Orfiril, Petilin, Valepil, Valhel PR, Valpal, Valpro ja Valprolek.
English: • Healthcare professionals will receive further information at national level in due course as the recommendations are implemented.
Estonian: • Lisateave tervishoiutöötajale avaldatakse riigi tasandil kohe, kui soovitused jõustatakse.
English: The programme is designed to ensure that patients are made fully aware of the risks and the need to avoid becoming pregnant.
Estonian: Kava eesmärk on tagada, et patsiendid teadvustavad täielikult riske ja vajadust vältida rasestumist.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Estonian: See vastutab ühtlustatud ohutusstandardite tagamise eest ravimitele, mis on saanud Euroopa Liidus müügiloa riiklike menetluste kaudu.
English: • It is important that patients discuss any concerns about their medication with an appropriate healthcare professional.
Estonian: • On oluline, et patsiendid arutaksid kõiki ravimiga seotud küsimusi asjakohase tervishoiutöötajaga.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/145600/2018
Estonian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United
English: In addition, all companies marketing such medicines will need to have in place a risk management plan which details the measures taken to ensure that a medicine is used as safely as possible.
Estonian: Peale selle peab nende ravimite kõigil turustajatel olema riskijuhtimiskava, milles sätestatakse ravimi võimalikult ohutu kasutamise meetmed.
English: In some EU Member States they are also authorised to prevent migraine headaches.
Estonian: Mõnes Euroopa Liidu liikmesriigis on need heaks kiidetud ka migreenipeavalude ennetamiseks.
English: − pregnancy tests before starting and during treatment as needed,
Estonian: rasedustestid enne ravi alustamist ja ravi ajal, vastavalt vajadusele;
English: Valproate medicines have been authorised via national procedures in all EU Member States and in Norway and Iceland.
Estonian: Valproaati sisaldavad ravimid on riiklike menetlustega heaks kiidetud kõigis Euroopa Liidu liikmesriikides ning Norras ja Islandil.
English: During the review, the PRAC also consulted very widely with healthcare professionals and with patients, including women and their children who have been affected by valproate use during pregnancy, through written submissions, expert meetings, meetings with stakeholders (including healthcare professionals, patients organisations, patients and their families), and via a public hearing.
Estonian: Läbivaatamismenetluse ajal konsulteeris ravimiohutuse riskihindamise komitee rohkesti ka tervishoiutöötajate ja patsientidega, sealhulgas valproaadi rasedusaegsest kasutamisest mõjutatud naiste ja lastega, kasutades kirjalikke arvamusi, ning eksperdikohtumisi, kohtumisi sidusrühmadega (sh tervishoiutöötajate, patsiendiorganisatsioonide, patsientide ja nende perekondadega) ning avalikku arutelu.
English: The review was first carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which has made a set of recommendations.
Estonian: Esmase läbivaatamise tegi inimravimite ohutusprobleemide hindamise eest vastutav ravimiohutuse riskihindamise komitee, kes koostas soovitused.
English: More about the medicine
Estonian: Ravimite lisateave
English: Women and girls who have been prescribed valproate should not stop taking their medicine without consulting their doctor as doing so could result in harm to themselves or to an unborn child.
Estonian: Naised ja tüdrukud, kellele on määratud valproaatravi, ei tohi lõpetada ravimi võtmist ilma arstiga nõu pidamata, sest see võib kahjustada neid või loodet.
English: The measures are based on a review of available scientific evidence, including drug utilisation studies and clinical and laboratory evidence of the effects of the medicine.
Estonian: Meetmed põhinevad kättesaadavate teaduslike tõendite, sealhulgas ravimikasutusuuringute ning ravimi toime kliiniliste ja laboriandmete läbivaatamisel.
English: The PRAC recommendations were sent to Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which has adopted a position.
Estonian: Komitee soovitused saadeti inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühmale, kes võttis vastu seisukoha.
English: • In pregnancy, valproate is contraindicated and an alternative treatment should be decided on, with appropriate specialist consultation, for women planning pregnancy; however, there may be a small number of women with epilepsy for whom there is no suitable alternative treatment to valproate and who should be appropriately supported and counselled.
Estonian: • Valproaat on raseduse ajal vastunäidustatud ning rasedust kavandavatel naistel tuleb eriarstiga konsulteerides leida ravialternatiiv; samas võib olla väike arv selliseid epilepsiaga naispatsiente, kellel puuduvad sobivad ravialternatiivid valproaadile ning keda tuleb asjakohasel viisil toetada ja nõustada.
English: It is known that if taken in pregnancy they can cause malformations in the baby and developmental disorders after birth.
Estonian: Teadaolevalt võivad need ravimid rasedusaegsel kasutamisel põhjustada väärarendeid ja kaasasündinud arenguhäireid.
English: The active ingredient in these medicines may be valproic acid, magnesium valproate, sodium valproate, valproate semisodium or valpromide.
Estonian: Need ravimid võivad toimeainena sisaldada valproehapet, magneesiumvalproaati, naatriumvalproaati, seminaatriumvalproaati või valpromiidi.
English: In addition, there will be a patient alert card attached to the packaging so that pharmacists can go through it with the patient when the medicine is dispensed.
Estonian: Peale selle kinnitatakse pakenditele patsiendi hoiatuskaart, et apteekrid saaksid seda ravimi väljastamisel patsiendiga arutada.
English: • Although steps had been taken previously to better inform women about these risks and discourage use of valproate in girls and women unless there was no alternative, the evidence shows that this information is still not getting to patients.
Estonian: • Kuigi olid olemas meetmed eesmärgiga tagada naiste parem teavitamine nendest riskidest ja vältida valproaadi kasutamist naissoost patsientidel, v.a kui ravialternatiivide puudumisel, nähtub tõenditest, et patsiendid ei saa endiselt vajalikku teavet.
English: − counselling about the risks of valproate treatment and the need for effective contraception throughout treatment,
Estonian: nõustamine valproaatravi riskide kohta ja vajaduse kohta kasutada ravi ajal efektiivseid rasestumisvastaseid vahendeid;
English: This will include surveys of healthcare professionals and patients to assess the reach and effectiveness of the new measures, and use of data from existing registries to further characterise the malformations known as foetal anticonvulsant syndrome in children whose mothers took valproate in pregnancy and how this compares to other anti-epileptic medicines.
Estonian: Muu hulgas peavad nad tegema tervishoiutöötajate ja patsientide küsitlusuuringud, et hinnata uute meetmete kasutamise ulatust ja efektiivsust, kirjeldama olemasolevatest registritest pärit andmete alusel täiendavalt väärarendit fetaalne antikonvulsandi sündroom lastel, kelle emad kasutasid raseduse ajal valproaati, ning võrdlema seda muude epilepsiaravimitega.
English: • Educational materials in the form of guides for patients and doctors will also be updated to reflect the current situation and provide age-appropriate advice.
Estonian: • Ajakohastatakse ka teabematerjale ehk juhendeid patsientidele ja arstidele, et kajastada praegust olukorda ja esitada vanuserühmadele kohandatud teave.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Estonian: Koordineerimisrühm on Euroopa Liidu liikmesriike ning Islandit, Liechtensteini ja Norrat esindav organ.
English: • As before, valproate treatment should never be started unless alternative treatments are not suitable, including in young girls below the age of puberty.
Estonian: • Nagu varemgi, tohib valproaatravi alustada üksnes siis, kui puuduvad sobivad ravialternatiivid, sealhulgas puberteedieelsetel tüdrukutel.
English: The medicines authorities in the individual countries will approve appropriate details of the visual warning for their national situation.
Estonian: Visuaalse hoiatuse üksikasjad otsustavad liikmesriikide ravimiametid vastavalt riigi olukorrale.
English: The new measures include a ban on the use of such medicines for migraine or bipolar disorder during pregnancy, and a ban on treating epilepsy during pregnancy unless there is no other effective treatment available.
Estonian: Uued meetmed hõlmavad selliste ravimite rasedusaegse kasutamise keelamist migreeni või bipolaarse häire korral ja epilepsia raviks, v.a kui muu efektiivne ravi puudub.
English: Because the CMDh position was agreed by majority vote it will now be sent to the European Commission, which will take a final legally binding decision valid across the EU.
Estonian: Et inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühma arvamus võeti vastu häälteenamusega, saadeti see Euroopa Komisjonile, kes tegi kogu Euroopa Liidus kehtiva lõpliku õiguslikult siduva otsuse.
English: It also includes a retrospective observational study to look at any association between exposure to valproate in men and the risk of malformations and developmental disorders including autism in offspring, and an observational study to evaluate and identify the best practice for stopping and switching of valproate treatment.
Estonian: Samuti hõlmavad uuringud retrospektiivset vaatlusuuringut, et leida, kas valproaadi kasutamine meestel on seotud järglaste väärarendite ja arenguhäirete (sh autismi) riskiga, ning vaatlusuuringut eesmärgiga hinnata ja tuvastada valproaatravi katkestamise ja asendamise parim tava.
English: • Medicines containing valproate have been available in EU countries for many years to treat epilepsy, bipolar disorder and in some countries migraine.
Estonian: • Valproaati sisaldavaid ravimeid on Euroopa Liidu liikmesriikides aastaid turustatud epilepsia, bipolaarse häire ja mõnes riigis migreeni raviks.
English: − introduction of a new risk acknowledgement form that patients and prescribers will go through at each such annual review to confirm that appropriate advice has been given and understood.
Estonian: uue riskide kinnitusvormi kasutuselevõtt, mille patsient ja ravimi määraja täidavad ravi igaaastasel läbivaatamisel, kinnitades, et patsiendile on antud asjakohane teave ja patsient on seda mõistnud.
English: The CMDh agreed with EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which carried out a review and recommended the new measures, that despite previous recommendations aimed at better informing patients of the risks with these medicines, women were still not always receiving the right information in a timely manner.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm nõustus teabe läbivaatamise korraldanud ja uued meetmed soovitanud ravimiohutuse riskihindamise komiteega, et kuigi olid olemas varasemad soovitused eesmärgiga tagada patsientide parem teavitamine nende ravimite riskidest, ei saanud paljud naised endiselt õiget ega õigeaegset teavet.
English: Valproate medicines are used to treat epilepsy and bipolar disorder.
Estonian: Valproaati sisaldavaid ravimeid kasutatakse epilepsia ja bipolaarse häire raviks.
English: A visual warning of the pregnancy risks (in the form of boxed text with other possible elements such as a warning symbol) must also be placed on the packaging of the medicines and warnings be included on patient cards attached to the box and supplied with the medicine each time it is dispensed.
Estonian: Samuti tuleb ravimipakenditele lisada rasedusaegsete riskide visuaalne hoiatus (raamitud tekst ja võimalikud muud elemendid, nt hoiatussümbol) ning pakendile kinnitatud ja koos ravimiga väljastatavatele patsiendikaartidele tuleb lisada hoiatused.
English: − an assessment of each patient's potential for becoming pregnant,
Estonian: patsiendi rasestumisvõime hindamine;
English: The new measures endorsed by CMDh therefore strengthen previous restrictions on valproate use and requirements to inform women of the risk.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühma heakskiidetud uute meetmetega täiendatakse seega varasemaid valproaadi kasutamise piiranguid ja naistele riskide teatamise nõudeid.
English: 1 The CMDh is a medicines regulatory body representing the European Union (EU) Member States, Iceland, Liechtenstein and Norway.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm on Euroopa Liidu liikmesriike, Islandit, Liechtensteini ja Norrat esindav ravimite reguleerimise organ.
English: Further, the medicines must not be used in any woman or girl able to have children unless the conditions of a new pregnancy prevention programme are met.
Estonian: Peale selle ei tohi neid ravimeid kasutada rasestumisvõimelised naispatsiendid, v.a kui uue rasedusennetuskava tingimused on täidetud.
English: Valproate-containing medicines have been approved nationally in the EU to treat epilepsy and bipolar disorder and in some countries for prevention of migraine.
Estonian: Valproaati sisaldavad ravimid on Euroopa Liidus riiklikult heaks kiidetud epilepsia ja bipolaarse häire raviks ning mõnes riigis migreeni ennetamiseks.
English: • There will be changes to the product information (package leaflet for patients and SmPC for healthcare professionals) to reflect these new conditions and also to the packaging of the medicine, including a visual warning in the form of boxed text which may be accompanied by other elements such as a symbol.
Estonian: • Nende uute tingimuste kajastamiseks muudetakse ravimiteavet (pakendi infolehte patsientidele ja ravimi omaduste kokkuvõtet tervishoiutöötajatele) ning ravimipakendeid, lisades visuaalse hoiatuse - raamitud teksti koos võimalike muude elementidega (nt sümbol).
English: Companies marketing these medicines are also required to carry out additional studies on the nature and extent of the risks and to monitor valproate use and the long-term effects from affected pregnancies.
Estonian: Nende ravimite turustajad peavad tegema ka riskide olemuse ja ulatuse täiendavad uuringud ning jälgima toimuvat valproaatravi ja valproaadi rasedusaegse kasutamise pikaajalist mõju.