natgillin/translations-raw huggingface dataset:
Der findes en publiceret kasuistik, der også viser en mulig risiko ved kombination af memantin og fenytoin. • Andre aktive stoffer såsom cimetidin, ranitidin, procainamid, quinidin, quinin og nikotin, der bruger samme renale kationiske transportsystem som amantadin, kan muligvis også have interaktion med memantin, hvilket kan medføre en risiko for forhøjede plasmaniveauer. • Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT. • Efter markedsføringen er der rapporteret enkeltstående tilfælde af stigninger i International normalized ratio (INR) hos patienter i samtidig behandling med warfarin.
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Der sås ingen relevante interaktioner mellem de aktive stoffer i memantin og glyburid/ metformin henholdsvist donepezil i enkeltdosis farmakokinetiske (PK) - studier hos yngre, raske forsøgspersoner.
In single-dose pharmacokinetic (PK) studies in young healthy subjects no relevant active substance-active substance interaction of memantine with glyburide/ metformin or donepezil was observed.
Derudover har Axura mindre til moderat indflydelse på evnen til at føre motorkøretøj eller betjene en maskine, hvorfor ambulante patienter skal gøres opmærksom på at være særligt forsigtige.
Furthermore, Axura has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
I kliniske forsøg med 1. 784 patienter i behandling med Axura for mild til svær demens og med 1. 595 patienter i placebobehandling adskilte den generelle incidensrate for bivirkninger med Axura sig ikke fra placebobehandlingen, og bivirkningerne var som regel milde til moderate.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Meget almindelig (≥1/ 10), almindelig (≥1/ 100 til < 1/ 10), ikke almindelig (≥1/ 1. 000 til < 1/ 100), sjælden (≥1/ 10. 000 til < 1/ 1. 000), meget sjælden (< 1/ 10. 000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
12 Cardiac disorders
12 Hjertelidelser Lidelser i nervesystemet
Cardiac failure
Ikke almindelig Almindelig Ikke almindelig Meget sjælden
Nervous system disorders
2 Enkeltstående tilfælde rapporteret efter markedsføringen.
2 Isolated cases reported in post-marketing experience
Alzheimers sygdom er blevet sat i forbindelse med depression, selvmordsforestilling og selvmord.
Alzheimer’ s disease has been associated with depression, suicidal ideation and suicide.
I tilfælde af overdosering med doser under 140 mg eller ukendt dosis har patienterne haft symptomer fra centralnervesystemet (forvirring, døsighed, sløvhed (søvntrang), svimmelhed, agitation, aggression, hallucinationer og gangforstyrrelser) og/ eller fra mave- tarmkanalen (opkastning og diarré).
In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination and gait disturbance) and/ or gastrointestinal origin (vomiting and diarrhoea).
I det alvorligste tilfælde af overdosering overlevede patienten en peroral indtagelse af i alt 2. 000 mg memantin med virkninger på centralnervesystemet (koma i 10 dage, og senere hen diplopi og agitation).
In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
I et andet tilfælde med stor overdosis overlevede patienten også og kom sig.
13 In another case of a large overdose, the patient also survived and recovered.
13 5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties
Andre antidemenspræparater, ATC- kode:
Other Anti-dementia drugs, ATC code:
Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (” observed cases analysis ” for Clinician´s interview based impression of change (CIBIC- plus): p=0, 025; Alzheimer´s disease cooperative study – activities of daily living (ADCS- ADLsev): p=0, 003; Severe impairment battery (SIB): p=0, 002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Alzheimer´s disease assessment scale (ADAS- cog) (p=0, 003) og CIBIC- plus (p=0, 004) i uge 24 Last observation carried forward (LOCF).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Absorption:
14 Absorption:
Ved indgivelse af daglige doser på 5 til 30 mg udregnedes en gennemsnitlig cerebrospinalvæske (CSF) / serumværdi på 0, 52.
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/ serum ratio of 0.52 was calculated.
14 I et studie med peroral indgivelse af 14C- memantin blev gennemsnitligt 84% af dosis udskilt inden for 20 dage, mere end 99% blev udskilt via nyrerne.
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
Ved en dosis af memantin på 20 mg pr. dag svarer CSF- niveauernetil ki- værdien (ki = hæmningsfaktor) for memantin, som er 0, 5 µmol i den humane frontale cortex.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
15 6. 3 Opbevaringstid
6.3 Shelf life
Må ikke opbevares over 30ºC.
Do not store above 30ºC.
Brune glasflasker (hydrolytisk klasse III) med dråbetæller indeholdende enten 20, 50, 100 g eller 10 x 50 g opløsning.
Brown glass bottles (Hydrolytic Class III) with dropper containing either 20, 50, 100 g or 10 x 50 g solution.
100 D- 60318 Frankfurt/ Main Tyskland.
100 D-60318 Frankfurt/ Main Germany
MM/ ÅÅÅÅ
16 MM/ YYYY
Axura 15 mg filmovertrukne tabletter.
Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets.
Hver tablet indeholder 5 mg memantinhydrochlorid svarende til 4, 15 mg memantin.
Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Hver tablet indeholder 10 mg memantinhydrochlorid svarende til 8, 31 mg memantin.
Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Hver tablet indeholder 15 mg memantinhydrochlorid svarende til 12, 46 mg memantin.
Each film-coated tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Hver tablet indeholder 20 mg memantinhydrochlorid svarende til 16, 62 mg memantin.
Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
4. 4.
The 10 mg film-coated tablet contains 166 mg lactose, see section 4.4.
De hvide til grålighvide filmovertrukne tabletter på 5 mg er ovale- aflange tabletter præget med ” 5 ” på den ene side og ” MEM ” på den anden side.
The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘ 5 ’ on one side and imprint ‘ MEM’ on the other side.
De hvide til grålighvide filmovertrukne tabletter på 10 mg er aflange og indsnævrende mod midten, bikonvekse med delekærv på begge sider.
The 10 mg film-coated tablets are white to off-white film-coated tablets, centrally tapered oblong, biconvex, with a single breakline on both sides.
De orange til gråligorange filmovertrukne tabletter på 15 mg er ovale- aflange tabletter præget med ” 15 ” på den ene side og ” MEM ” på den anden side.
The 15 mg film-coated tablets are orange to grey-orange, oval-oblong film-coated tablets with imprint ‘ 15 ’ on one side and imprint ‘ MEM’ on the other side.
De svagt røde til gråligrøde filmovertrukne tabletter på 20 mg er ovale- aflange tabletter præget med ” 20 ” på den ene side og ” MEM ” på den anden side.
The 20 mg film-coated tablets are pale red to grey-red, oval-oblong film-coated tablets with imprint ‘ 20 ’ on one side and imprint ‘ MEM’ on the other side.
Voksne/ ældre:
Adults:
Den anbefalede startdosis er 5 mg pr. dag med gradvis dosisøgning over de første fire uger som følger:
Dose titration The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Patienten bør indtage en 5 mg filmovertrukket tablet dagligt (hvid til grålighvid, oval- aflang) i 7 dage..
18 The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
17 2. uge (dag 8- 14):
Week 2 (day 8-14):
Patienten bør indtage én filmovertrukken 10 mg- tablet dagligt (hvid til grålighvid, aflang og indsnævrende mod midten, bikonveks med delekærv på begge sider) i 7 dage.
The patient should take one 10 mg film-coated tablet per day (white to off-white, centrally tapered oblong, biconvex, with a single breakline on both sides) for 7 days.
Patienten bør indtage én filmovertrukket 15 mg- tablet dagligt (grålig orange, oval- aflang) i 7 dage.
The patient should take one 15 mg film-coated tablet per day (greyorange, oval-oblong film) for 7 days.
4. uge (dag 22- 28):
Week 4 (day 22-28):
Patienten bør indtage én filmovertrukket 20 mg- tablet dagligt (grålig rød, oval- aflang) i 7 dage.
The patient should take one 20 mg film-coated tablet per day (grey-red, oval-oblong film) for 7 days.
Hos patienter med let nedsat nyrefunktion (kreatinin- clearance 50- 80 ml/ min) er dosisjustering ikke påkrævet.
In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/ min) no dose adjustment is required.
18 Hjælpestoffer:
19 Excipients:
Tabletterne indeholder lactosemonohydrat.
The 10 mg film-coated tablets contain lactose monohydrate.
Samtidig administration af memantin og antispastika, dantrolen eller baklofen, kan modificere disses virkninger, og en dosisjustering kan være nødvendig. • Samtidig brug af memantin og amantadin skal undgås på grund af risikoen for farmakotoksisk psykose.
Concomitant administration of memantine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary. • Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
• Andre aktive stoffer såsom cimetidin, ranitidin, procainamid, quinidin, quinin og nikotin, der bruger samme renale kationiske transportsystem som amantadin, kan muligvis også have interaktion med memantin, hvilket kan medføre en risiko for forhøjede plasmaniveauer. • Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT. • Efter markedsføringen er der rapporteret enkeltstående tilfælde af stigninger i international normalized ratio (INR) hos patienter i samtidig behandling med warfarin.
There is one published case report on a possible risk also for the combination of memantine and phenytoin. • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
19 I kliniske forsøg med 1. 784 patienter i behandling med Axura for mild til svær demens og med 1. 595 patienter i placebobehandling adskilte den generelle incidensrate for bivirkninger med Axura sig ikke fra placebobehandlingen, og bivirkningerne var som regel milde til moderate.
In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ 20 from those with placebo; the adverse reactions were usually mild to moderate in severity.
Hjertelidelser Lidelser i nervesystemet:
Cardiac disorders
Der er kun begrænset erfaring med overdosering fra kliniske studier og efter markedsføring.
21 Only limited experience with overdose is available from clinical studies and post-marketing experience.
20 I et andet tilfælde med stor overdosis overlevede patienten også og kom sig.
In another case of a large overdose, the patient also survived and recovered.
Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (” observed cases analysis ” for Clinician' s interview based impression of change (CIBIC- plus): p=0, 025; Alzheimer´s disease cooperative study – activities of daily living (ADCS- ADLsev): p=0, 003; SIB: p=0, 002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician’ s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study- activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Alzheimer´s disease assessment scale (ADAS- cog) (p=0, 003) og CIBIC- plus (p=0, 004) i uge 24 (Last observation carried forward (LOCF)).
Alzheimer’ s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
I den prospektivt definerede primære analyse opnåedes der ikke statistisk signifikans på det primære effektmål i uge 24.
22 In the prospectively defined primary analysis statistical significance was not reached at the primary efficacy endpoint at week 24.
21 Absorption:
Absorption:
I et studie med peroral indgivelse af 14C- memantin blev gennemsnitligt 84% af dosis udskilt inden for 20 dage, mere end 99% blev udskilt via nyrerne.
In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20 days, more than 99% being excreted renally.
Fosfolipidose i pulmonale makrofager på grund af akkumulation af memantin i lysosomer blev observeret hos gnavere.
23 Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Tabletkerne for 5/ 15/ 20 mg filmovertrukne tabletter:
Tablet cores for 5/ 15/ 20 mg film-coated tablets:
Mikrokrystallinsk cellulose Croscarmellosenatrium Kolloidt vandfrit silika Magnesiumstearat
Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Tabletovertræk for 5/ 15/ 20 mg filmovertrukne tabletter:
Tablet coat for 5/ 15/ 20 mg film-coated tablets:
Hypromellose Macrogol 400 Titandioxid (E 171)
Hypromellose Macrogol 400 Titanium dioxide (E 171)
Tabletkerne for 10 mg filmovertrukne tabletter:
Tablet core for 10 mg film-coated tablet:
Tabletovertræk for 10 mg filmovertrukne tabletter:
Tablet coat for 10 mg film-coated tablet:
Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen.
24 This medicinal product does not require any special storage conditions.
Hver pakke indeholder 28 filmovertrukne tabletter i 4 PVDC/ PE/ PVC/ Alu- blisterstrips eller PP/ Alu- blisterstrips med 7 filmovertrukne tabletter på 5 mg, 7 filmovertrukne tabletter på 10 mg, 7 filmovertrukne tabletter på 15 mg og 7 filmovertrukne tabletter på 20 mg
Each pack contains 28 film-coated tablets in 4 PVDC/ PE/ PVC/ Al-blister or PP/ Al-blisters with 7 film-coated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film- coated tablets of 20 mg.
08/ 05/ 2008 Dato for seneste genregistrering:
08/ 05/ 2008 Date of latest renewal:
Svagt røde til gråligrøde, filmovertrukne tabletter på 20 mg, ovale- aflange, præget med ” 20 ” på den ene side og ” MEM ” på den anden side.
Pale red to grey-red, oval-oblong film-coated tablets with imprint “ 20 ” on one side and imprint “ MEM” on the other side.
Patienten bør indtage en filmovertrukken 5 mg- tablet dagligt i 7 dage.
The patient should take one 5 mg film-coated tablet per day for 7 days.
Patienten bør indtage en filmovertrukken 10 mg- tablet dagligt i 7 dage.
The patient should take one 10 mg film-coated tablet per day for 7 days.
Patienten bør indtage en filmovertrukken 15 mg- tablet dagligt i 7 dage.
The patient should take one 15 mg film-coated tablet per day for 7 days.
Patienten bør indtage en filmovertrukken 20 mg- tablet dagligt i 7 dage.
The patient should take one 20 mg film-coated tablet per day.
Den anbefalede vedligeholdelsesdosis er 20 mg dagligt.
Maintenance dose The recommended maintenance dose is 20 mg per day.
25 Ældre:
26 Elderly:
26 • Andre aktive stoffer såsom cimetidin, ranitidin, procainamid, quinidin, quinin og nikotin, der bruger samme renale kationiske transportsystem som amantadin, kan muligvis også have interaktion med memantin, hvilket kan medføre en risiko for forhøjede plasmaniveauer. • Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT. • Efter markedsføringen er der rapporteret enkeltstående tilfælde af stigninger i international normalized ratio (INR) hos patienter i samtidig behandling med warfarin.
27 • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels. • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT. • In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
27 Hjertelidelser Lidelser i nervesystemet:
Cardiac disorders
Behandling:
29 Treatment:
28 5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties
Undersøgelsen viste en gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (” observed cases analysis ” for Clinician' s interview based impression of change (CIBIC- plus): p=0, 025; Alzheimer´s disease cooperative study – activities of daily living (ADCS- ADLsev): p=0, 003; SIB: p=0, 002).
The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study – activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Alzheimer´s disease assessment scale (ADAS- cog) (p=0, 003) og CIBIC- plus (p=0, 004) i uge 24 (Last observation carried forward (LOCF)).
Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) -and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Ved indgivelse af daglige doser på 5 til 30 mg udregnedes en gennemsnitlig (cerebrospinalvæske) CSF/ serumværdi på 0, 52.
Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ ml (0.5 - 1 µmol) with large interindividual variations.
Distributionsvolumen er ca.
When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/ serum ratio of 0.52 was calculated.
29 Elimination:
Elimination:
Ved en dosis af memantin på 20 mg pr. dag svarer CSF- niveauerne til ki- værdien (ki = hæmningsfaktor) for memantin, som er 0, 5 µmol i den humane frontale cortex.
At a dose of memantine of 20 mg per day the (CSF) levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
Tabletovertræk:
Tablet coat:
Hypromellose Macrogol 400 Titandioxid (E 171) Gul og rød jernoxid (E 172)
Hypromellose Macrogol 400 Titanium dioxide (E 171) Iron oxide yellow and red (E 172)
30 6. 2 Uforligeligheder
6.2 Incompatibilities
PVDC/ PE/ PVC/ Alu- blisterstrip eller PP/ Alu- blisterstrip.
Blister packs containing 14 film-coated tablets per PVDC/ PE/ PVC/ Al-blister or PP/ Al-blister strip.
Der findes pakkestørrelser på 14, 28, 42, 56, 98 elle 840 (20 x 42) filmovertrukne tabletter.
Pack sizes of 14, 28, 42, 56, 98 or 840 (20 x 42) film-coated tablets are presented.
32 BILAG II
33 ANNEX II
FREMSTILLER( E) ANSVARLIG( E) FOR BATCHFRIGIVELSE
MANUFACTURNG AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
Merz Pharma GmbH + Co.
Merz Pharma GmbH & Co.
• ANDRE BETINGELSER.
• OTHER CONDITIONS
Bivirkningsovervågningssystem Før lægemidlet markedsføres, og så længe det markedsførte lægemiddel anvendes, skal indehaveren af markedsføringstilladelsen sikre, at der er etableret et bivirkningsovervågningssystem, og at det fungerer, som beskrevet i markedsføringstilladelsen version 2. 0 (7. maj 2007), modul 1. 8. 1.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 2.0 (7 May 2007) presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the product is on the market.
Risk Management Plan Indehaveren af markedsføringstilladelsen forpligter sig til at udføre undersøgelser og yderligere Bivirkningsovervågningsaktiviteter som beskrevet i Bivirkningsovervågningsplanen som aftalt i version 4 (7. februar 2008) af Risk Management Plan (RMP) beskrevet i modul 1. 8. 2. af markedsføringstilladelsen og alle eventuelle opdateringer af RMP, som aftalt af CHMP (The Committee for Medicinal Products for Human Use – Udvalget for Humanmedicinske Lægemidler).
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 4 (7 February 2008) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
I henhold til Udvalget for Humanmedicinske Lægemidlers retningslinier for risikohåndteringssystemer (CHMP Guideline on Risk Management Systems) for lægemidler til humant brug, bør RMP- opdateringer fremsendes samtidig med den næste Periodiske sikkerhedsopdatering (Periodic Safety Update Report (PSUR)).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updates RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Derudover bør en opdateret RMP fremsemdes • Når der fås ny information, som kan få indflydelse på den aktuelle sikkerhedsspecifikation, bivirkningsovervågningsplan eller risikominimerende aktiviteter • Inden for 60 dage fra en milepæl af særlig betydning (vedr. bivirkningsovervågning eller risikominimering) er nået • Ved anmodning fra EMEA
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA