natgillin/translations-raw huggingface dataset:
krampe anfald, blod eller størknet blod i afføringen (eller sort, tjæret afføring)
convulsion (“fit”), blood or clots in stool (or black, tarry stool),
krampe i mundmuskulaturen, hævede led
pasm of mouth muscle, joint swelling
Krampe#
Convulsion#
Krampe*.
Convulsion*.
Krampe- anfald
Loss of consciousness Convulsion
Krampe: snæver Standardiseret MedDRA Forespørgsel (SMF) ”Kramper”
Convulsion: narrow SMQ “Convulsions”
Krampeanf ald
Convulsions
Krampeanfald
Convulsions (fits and seizures)
Krampeanfald
Convulsions (fits)
krampeanfald
eizure
krampeanfald
eizure (fits)
krampeanfald
eizures
krampeanfald
eizures,
Krampeanfald
Fits
krampeanfald
fits (convulsions)
Krampeanfald
Fits (seizures)
krampeanfald
fits or convulsions
krampeanfald
fits or seizures
Krampeanfald
Gait abnormal Seizures
Krampeanfald
Seizure
Krampeanfald
Seizure disorders
Krampeanfald
Seizures and convulsions
krampeanfald (anfald eller kramper).
eizures (fits or convulsions).
Krampeanfald (kan forekomme hos op til 1 ud af 100 personer) – når kroppen ryster hurtigt og ukontrollabelt, er der tale om et krampeanfald.
Convulsions (may affect up to 1 in 100 people) – convulsions (fits) are when a person's body shakes rapidly and uncontrollably.
krampeanfald (kramper)
convulsion (fits)
krampeanfald (krampetrækninger)
eizures (convulsions)
Krampeanfald Encefalopati Hjerneblødning
Seizure Encephalopathy Cerebral haemorrhage
krampeanfald et specielt leverenzym (gamma-GT), som dannes i leveren, kan øges (viser sig i blodprøver)
convulsion, a specific liver enzyme (gamma GT) which is produced by your liver, may rise (this will show up in blood tests),
Krampeanfald forekommee med hyppigheden ikke almindelig hos patienter i behandling med olanzapin.
Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
krampeanfald forvirring
eizure (fits) confusion
krampeanfald i
Discontinuation
krampeanfald i
factors for seizures
krampeanfald i
for seizures were
krampeanfald i
history of seizures
krampeanfald i anamnesen eller
reported 11
Krampeanfald kan forekommer med hyppigheden ikke almindelig hos patienter i behandling med olanzapin.
Seizures have been reported to occur uncommonly in patients when treated with olanzapine.
krampeanfald med eller uden feber episoder med shock-lignende tilstand eller bleghed, slaphed og passivitet
Fits (convulsions) with or without fever episodes of shock-like state or paleness, floppy and unresponsive
krampeanfald med eller uden høj feber inden for 3 dage efter vaccinationen hvis dit barn har en ikke-diagnosticeret eller fremskridende lidelse i hjernen, eller en ikke-kontrolleret epilepsi.
fits with or without a high temperature within 3 days of vaccination if your child has an undiagnosed or progressive disease of the brain or epilepsy which is not controlled.
krampeanfald med eller uden høj feber inden for 3 dage efter vaccinationen. dit barn har en ikke-diagnosticeret eller fremskridende lidelse i hjernen eller en ikke-kontrolleret epilepsi.
fits with or without a high temperature within 3 days of vaccination your child has an undiagnosed or progressive disease of the brain or epilepsy which is not controlled.
Krampeanfald nældefeber
fits hives
Krampeanfald og krampelidelser
Seizures and seizure disorders
Krampeanfald Seponér BLINCYTO permanent, hvis der er mere end ét krampeanfald.
Discontinue BLINCYTO permanently if more than one convulsion occurs.
krampeanfald uden feber eller pga. høj feber
fits without temperature or due to high temperature (fever)
Krampeanfald uden feber; feberkramper hos børn; usikker gang; svimmelhed; sygdomme, som involverer betændelse i nervesystemet (hjerne og/eller rygmarv).
Seizures (fits) without fever; seizures (fits) with fever in children; walking unsteadily; dizziness; illnesses involving inflammation of the nervous system (brain and/or spinal cord).
Krampeanfald var en sjælden bivirkning.
Seizures were rare adverse reactions.
Krampeanfald ved seponering
Withdrawal seizures
krampeanfald – i givet fald vil din læge overvåge dig tættere
fits (seizures) since your doctor may want to monitor you more closely
Krampeanfald**
Convulsion
krampeanfald,
eizures
Krampeanfald,
Seizures where in
Krampeanfald,
Seizures where in most
krampeanfald, besvimelse eller ørhed, svimmelhed
eizure, fainting or feeling faint, dizziness,
krampeanfald, besvimelse, rastløs trang til at bevæge kroppen, svimmelhed efter at have rejst sig op, opmærksomhedsforstyrrelse, talebesvær, tab af eller unormal smagssans, nedsat følelse i huden over for smerte og berøring, prikkende eller stikkende fornemmelse i huden eller følelsesløshed
convulsion (fits), fainting, a restless urge to move parts of your body, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness of skin
krampeanfald, blod eller størknet blod i afføringen (eller sort, tjæret afføring)
convulsion (“fit”), blood or clots in stool (or black, tarry stool),
Krampeanfald, delirium, hallucinationer, uro, dyskinesi, hyperkinesi, poriomani, svimmelhed, hovedpine, rastløshed, stupor
Seizure, delirium, hallucinations, agitation, dyskinesia, hyperkinesia, poriomania, dizziness, headache, restlessness, stupor
Krampeanfald, feberkramper
Seizure, febrile seizure
krampeanfald, forvirring, opfattelse af at se eller høre ting, der ikke er virkelige (hallucinationer), opstemthed, manglende evne til at kontrollere bevægelserne, tendens til at spekulere, svimmelhed, hovedpine, rastløshed, mangel på energi
fits, feeling confused, seeing or hearing things that are not real (hallucinations), feeling excited, movements that you cannot control, a tendency to wonder away, feeling dizzy, headache, feeling restless, lacking energy
Krampeanfald, hovedpiner, konfusion eller problemer med at koncentrere sig.
Seizures, headaches, confusion, or finding it difficult to concentrate.
Krampeanfald, hvor der i de fleste tilfælde var rapporteret
Seizures where in most cases a history of seizures
Krampeanfald, hvor der i de fleste tilfælde var rapporteret
Seizures where in most cases a history of seizures or risk factors for seizures were
Krampeanfald, hvor der i de fleste tilfælde var rapporteret
Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Krampeanfald, hvor der i de fleste tilfælde var rapporteret krampeanfald i
Seizures where in most cases a history of seizures or risk
Krampeanfald, hvor der i de fleste tilfælde var rapporteret krampeanfald i
Seizures where in most cases a history of seizures or risk factors for seizures were reported 11
Krampeanfald, hvor der i de fleste tilfælde var rapporteret krampeanfald i
Seizures where in most cases a history of seizures or risk factors for seizures were reported11
Krampeanfald, hvor der i de fleste tilfælde var rapporteret krampeanfald i anamnesen eller risikofaktorer for kramper11
Seizures where in most cases a history of seizures or risk factors for seizures were
krampeanfald, led- eller knoglesmerter, årebetændelse,
fit, joint or bone pain, inflammation of the blood vessels
Krampeanfald, rysten eller ukontrollerede muskelbevægelser, prikken eller unormal hudfornemmelse, øget muskelspænding, søvnighed, svimmelhed
Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness
Krampeanfald, rysten eller ukontrollerede muskelbevægelser, prikken eller unormale hudfornemmelser, øget muskelspænding, søvnighed, svimmelhed
Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness
Krampeanfald, rysten, træthedsfornemmelse, nedsat følesans
Seizure, tremor, feeling sluggish, less sensitive to touch
Krampeanfald, synkope, transitorisk cerebral iskæmi, ingen reaktion på stimulering, nedsat bevidsthedsniveau, tremor, døsighed
Convulsions, syncope, transient ischaemic attack, unresponsiveness to stimuli, depressed level of consciousness, tremor, somnolence
Krampeanfald, sædvanligvis hos patienter med tidligere krampeanfald (epilepsi).
eizures, usually associated with a history of seizures (epilepsy)
Krampeanfald, tremor, døsighed, brændende fornemmelse
Convulsion, Tremor, Somnolence, Burning sensation
Krampeanfald.
Convulsions.
Krampeanfald.
Fits.
Krampeanfald.
Seizures
Krampeanfald.
Seizures.
krampeanfald; manglende energi; inflammation i nerverne, som medfører følelsesløshed, svaghed og en snurrende fornemmelse eller brændende smerter i arme og ben
eizure; lack of energy; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs
Krampeanfaldet ikke stopper i løbet af 10 minutter
The seizure does not stop within 10 minutes
Krampeanfald†
Seizures
krampehæmmende og humørstabiliserende medicin, som bruges til behandling af epilepsi og bipolar sygdom (fx carbamazepin, phenobarbital, phenytoin, fosphenytoin, primidon);
anticonvulsant medicines and mood-stabilising medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
Kramper
Convulsion
kramper
convulsions
Kramper
Fits
kramper
fits (convulsions)
Kramper
Seizure
Kramper
Seizures
Kramper (anfald)
Convulsion (seizure)
Kramper (anfald) forbundet med hypoglykæmi (unormalt lave blodsukkerniveauer),
Convulsions (fits) linked to hypoglycaemia (abnormally low blood sugar levels),
kramper (krampeanfald),
convulsions (fits or seizures);
kramper (krampeanfald);
convulsions (fits or seizures);
Kramper (med og uden feber)
Convulsions (with or without fever)
Kramper eller krampeanfald - dette ses sjældent Andre bivirkninger:
Seizures or fits - this occurs rarely Other side effects:
Kramper eller krampeanfald - dette ses sjældent.
Seizures or fits - this occurs rarely.
kramper eller krampeanfald blødning eller tendens til blå mærker i højere grad end normalt
eizures or fits bleeding or bruising more easily than normal
kramper eller krampeanfald,
eizures (convulsions or fits)
kramper eller smertefulde, ømme eller svækkede muskler - dette kan være tegn på inflammation eller nedbrydning af musklerne, hvilket kan give nyreskade eller medføre død
cramps or painful, tender or weak muscles - these may be signs of muscle inflammation or breakdown, which can cause kidney damage or even death
kramper eller smerter i musklerne eller ufrivillige muskelsammentrækninger
muscle cramps, aches or spasms
Kramper forbundet med feber.
Convulsions associated with fever,
Kramper i benene
Leg cramps
Kramper i benene, knoglesmerter, smerter i bevægeapparatet
Leg cramps, bone pain, musculoskeletal pain
Kramper i benene.
Leg cramps.
kramper i lungeområdet
bronchospasm
Kramper Koma
Convulsions Coma
Kramper med eller uden feber*
Convulsions with or without fever
Kramper med eller uden feber, der opstår inden for 3 dage efter vaccination
Convulsions with or without fever, occurring within 3 days of vaccination.
Kramper med eller uden feber, der opstår inden for 3 dage.
Convulsions with or without fever, occurring within 3 days.
Kramper med eller uden feber, optrædende inden for 3 dage efter vaccinationen.
Convulsions with or without fever, occurring within 3 days of vaccination.
Kramper med eller uden feber, som optræder inden for 3 dage efter vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination.
kramper med eller uden feber, som optræder inden for 3 dage efter vaccination. tidligere har haft Guillain-Barré syndrom (midlertidig inflammation af nerver, der forårsager smerter, lammelse og føleforstyrrelser) eller brachial neuritis (alvorlig smerte og formindsket bevægelighed i arm og skulder) efter at have fået en tidligere vaccine, der indeholder tetanus toxoid (en inaktiveret form for stivkrampe).
fits (convulsions) with or without fever, occurring within 3 days of vaccination. previously had Guillain-Barré syndrome (temporary inflammation of nerves causing pain, paralysis and sensitivity disorders) or brachial neuritis (severe pain and decreased mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid (an inactivated form of tetanus toxin).
kramper og febervildelse (inklusiv ændret bevidsthedsniveau)
Convulsions and delirium, including altered level of consciousness
kramper og febervildelse inklusive ændret bevidsthedsniveau
Convulsions and delirium, including altered level of consciousness
kramper og muskelsmerter udslæt eller nældefeber et hvilket som helst sted på kroppen.
cramps and muscle pains skin rash or ‘hives’ anywhere on the body
kramper og muskelsmerter udslæt eller nældefeber på et hvilket som helst sted på kroppen.
cramps and muscle pains skin rash or ‘hives’ anywhere on the body
kramper og udtalt ekscitation med benzodiazepiner
Convulsions or pronounced excitation: treat with benzodiazepines
kramper,
eizure,
kramper, balanceforstyrrelser (problemer med at holde balancen), svimmelhed (følelse af usikker gang), letargi (mangel på energi og entusiasme), ufrivillig rysten (tremor)
convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
kramper, bevidsthedsforstyrrelse, encefalopati
seizure, impaired consciousness, encephalopathy
Kramper, bevidsthedssvækkelse, døsighed, afasi, nedsat balanceevne, svimmelhed, forvirring, nedsat
Convulsions, consciousness decreased, somnolence, aphasia, balance impaired, dizziness, confusion, memory impairment, concentration impaired, neuropathy, paresthesia, speech disorder, tremor
Kramper, chorea, myoclonia, døsighed, svaghed, træthed, hovedpine
Convulsions, chorea, myoclonia drowsiness, weakness, fatigue, headache
kramper, en følelse af at snurre rundt (vertigo)
convulsion, a feeling of ‘spinning’ (vertigo)
Kramper, feberkramper.
Convulsion, febrile convulsion.
Kramper, herunder feberkrampe
Seizures (or fits), including those caused by a high temperature
Kramper, herunder kramper forårsaget af feber
Seizures (or fits), including those caused by a high temperature
Kramper, hovedpine, forvirring eller problemer med at koncentrere sig.
Fits, headaches, confusion, or finding it difficult to concentrate.
Kramper, hypertoni, tremor, somnolens, hovedpine, paræstesier
Convulsion, hypertonia, tremor, somnolence, headache, paraesthesia
Kramper, hypæstesi og tetani (sekundært til
Convulsions, hypoaesthesia and tetany
Kramper, hævede øjne, anafylaktisk shock.
Convulsions, eye swelling and anaphylaxis.
kramper, inflammation i kranienerverne, påvirket koordination eller balance
seizure, cranial nerve inflammation, impaired coordination or balance
Kramper, koncentrationsbesvær, vrangforestillinger, paranoia, udslæt, hovedpine og mavesmerter.
Convulsion, disturbance in attention, delusion (false belief), paranoia, rash, headache and stomach pain.
Kramper, nedsat vejrtrækningsdybde eller -hastighed, nældefeber, selvmordstanker, kortvarige vejrtrækningspauser under søvn, eufori, mundtørhed, hævet ansigt (angioødem), dehydrering, panikanfald, mani/bipolar lidelse, vrangforestilling, bruksisme (tænderskæren og knytten kæbe), pollakisuri/imperiøs vandladning (hyppig vandladning), tinnitus (ringen og susen for ørerne), søvnrelateret spiseforstyrrelse og tab af bevidsthed.
Convulsion, decreased breathing depth or rate, hives, suicidal thoughts, short cessation of breathing during sleep, euphoric mood, dry mouth, swelling face (angioedema), dehydration , panic attack , mania / bipolar disorder , delusion , bruxism (teeth grinding and jaw clenching) , pollakiuria / micturition urgency (increase need to urinate) , tinnitus (noise in the ears such as ringing or buzzing) sleep-related eating disorder and loss of consciousness.
Kramper, nerveforstyrrelser
Convulsions, nerve problems
kramper, problemer med at holde balancen, svimmelhed (følelse af usikker gang), letargi (mangel på energi og entusiasme), tremor (ufrivillig rysten);
convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling)
kramper, problemer med at holde balancen, svimmelhed (følelse af usikker gang), letargi (mangel på energi og entusiasme), tremor (ufrivillig rysten);
convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
kramper, problemer med at holde balancen, svimmelhed (følelse af usikker gang), letargi (mangel på energi og entusiasme), tremor (ufrivillig rysten);
convulsion, balance disorder (equilibrium disorder),dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
kramper, synkope, tremor, hypertoni3, paræstesi, søvnighed, svimmelhed
convulsion, syncope, tremor, hypertonia3, paraesthesia, somnolence, dizziness
kramper, ændringer i mental status eller årvågenhed, søvnighed, problemer med at holde balancen, svimmelhed, konfusion, glemsomhed, koncentrationsproblemer, snurrende fornemmelser, prikken i huden, talebesvær eller vanskeligheder med at forstå sproget, rysten, slagtilfælde
fits, change in mental status or alertness, sleepiness, difficulty with your balance, dizziness, confusion, forgetfulness, difficulty concentrating, tingling sensation, “pins and needles”, difficulty speaking or understanding language, shaking, stroke.
Kramper, øget muskelspændinger, rysten og muskelsvaghed, ledsmerter
Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain
Kramper, øget muskelspændinger, rysten og muskelsvaghed, ledsmerter.
Convulsions, increased tension in the muscles, shaking and muscle weakness, joint pain
Kramper.
Convulsions
Kramper.
Convulsions.
Kramper/krampeanfald med eller uden høj temperatur indenfor 3 dage efter vaccinationen. hvis dit barn lider af en ikke-diagnostiseret eller en fremskridende sygdom i hjernen eller ukontrolleret epilepsi.
Seizures/fits with or without a high temperature within 3 days of vaccination if your child is suffering from an undiagnosed or progressive disease of the brain or uncontrolled epilepsy.
kramper11
Amnesia9
kramper11
Dystonia
kramper11
reported11
kramper11
symptoms7, 12
kramper11
symptoms7,12
Kramper3, amnesi3, abnorm tankevirksomhed3, ataksi3, unormal koordination3, agitation3, tremor
convulsions3, amnesia3, thinking abnormal3, ataxia3, coordination abnormal3, agitation3, tremor
Kramper: Snæver SMQ ”Kramper”
Convulsion: narrow SMQ “Convulsions”
Kramper٭
Seizure (convulsion)
Kramper٭
Seizure (convulsion)*,
KRAMPESTILLENDE LÆGEMIDLER
ANTICONVULSANTS
krampestillende lægemidler for at forebygge krampeanfald (phenytoin eller benzodiazepiner) og lægemidler mod kvalme for at forebygge opkastning.
anticonvulsive medicines to prevent seizures (phenytoin or benzodiazepines) and antiemetic medicines to prevent vomiting.
krampestillende midler (til at forebygge krampeanfald), for eksempel phenytoin, valproat eller carbamazepin
anticonvulsant medicines (used to prevent fits), such as phenytoin, valproate or carbamazepine
krampestillende midler (til behandling af epilepsi) og midazolam (anvendes som sovemedicin eller til behandling af epilepsi)
Anticonvulsants (for the treatment of epilepsy) and midazolam (used as sleeping pill and for the treatment of epilepsy);
krampestillende midler til behandling af epilepsi (fx carbamazepin, phenytoin, phenobarbital) visse antibiotika mod tuberkulose (rifabutin, rifampicin)
anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital) certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)
Krampetilfælde
Seizure disorders
krampetrækninger
convulsion
krampetrækninger eller krampeanfald besvimelse.
convulsions, fits or seizures fainting
kraniel
cranial
kraniel
cranial neuropathy8,
kraniel
ventricular
Kraniosynostose som en manifestation af hypophosphatasi er dokumenteret i den publicerede litteratur, og forekom hos 61,3 % af patienterne fra fødslen til 5 år i et naturligt historisk studie af ubehandlede patienter med hypophosphatasi med symptomdebut i spædbarnsalderen.
Craniosynostosis as a manifestation of hypophosphatasia is documented in published literature and occurred in 61.3% of patients between birth and 5 years of age in a natural history study of untreated infantile-onset hypophosphatasia patients.
KRAS (Kirsten rat sarcoma 2 viral oncogene homolog) og NRAS (Neuroblastoma RAS viral oncogene homolog) er kraftigt forbundne medlemmer af familien af RAS-onkogener.
KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) and NRAS (Neuroblastoma RAS viral oncogene homologue) are highly related members of the RAS oncogene family.
Krav i forbindelse med en opstået graviditet
Requirements in the event of pregnancy
Krav om at informere patienterne om den teratogene risiko, som er forbundet med Erivedge, og om nødvendigheden af at undgå føtal eksponering
A requirement to inform patients of the teratogenic risks associated with Erivedge and the need to avoid foetal exposure
Krav om at tørre såret med standardteknikker (f.eks. intermitterende applicering af kompres, servietter, sug), før produktet anvendes
Requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product
krav om at tørre såret ved brug af standardteknikker (f.eks. intermitterende applikation af kompresser, vatpinde, tamponer,brug af sugeanordninger), før produktet anvendes krav om tæt monitorering af blodtryk, puls, iltmætning og slut-tidal-CO2 under sprayen af produktet for forekomst af gasemboli. hvilke(n) regulator(er), der skal anvendes, i overensstemmelse med producentens anbefalinger og brugsanvisningen i produktresumeet
requirement to dry the wound using standard techniques (e.g., intermittent application of compresses, swabs, use of suction devices) prior to using the product requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2 when spraying the product, for the occurrence of gas embolism. which regulator(s) should be used, in line with manufacturer recommendations and the SmPC instructions for use
Krav om tæt monitorering af blodtryk, puls, iltmætning og sluttidal-CO2, når produktet sprøjtes, på grund af muligheden for gasemboli
Requirement to closely monitor blood pressure, pulse rate, oxygen saturation, and end tidal CO2 when spraying the product, for the occurrence of gas embolism
Krav til graviditetstests
Pregnancy testing requirements
Krav til infusion i hjemmet (hjemmets forhold, vurdering af patienten, nødbehandling),
Requirements for home infusion (home condition, patient assessment, emergency treatment);
Krav til svangerskabsforebyggelse, definition og nødvendighed af hensigtsmæssige svangerskabsforebyggende metoder
Pregnancy prevention requirement, definition and need for adequate contraceptive methods
Krav ved graviditet
Requirements in the event of pregnancy
Krav vedrørende indberetning af graviditet
Pregnancy reporting requirements
Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of
Kravene for fremsendelse af PSUR’er for dette lægemiddel fremgår af listen over EU- referencedatoer(EURD list), som fastat i artikel 107c, tykke 7, i direktiv 2001/83/EF og alle efterfølgendeopdateringer offentliggjort på den europæiske webportal for lægemidler.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.