natgillin/translations-raw huggingface dataset:
< 20 mg Kapslens indhold Sojaolie, renset Bivoks, gul Hydrogeneret vegetabilsk olie (fra sojaolie)
Soya-bean oil, refined Beeswax, yellow Hydrogenated vegetable oil (derived from soya-bean oil)
Kapslens skal Glycerol Gelatine Vand, renset Rød jernoxid (E172) Gul jernoxid (E172) Titandioxid (E171) Lecithin Triglycerider (middelkædelængde)
Glycerol Gelatin Water, purified Red iron oxide paste (E172) Lecithin Medium chain triglycerides
6. 2 Uforligeligheder
Capsule contents
Ikke relevant.
Capsule shell
6. 3 Opbevaringstid
Glycerol Gelatin Water, purified Red iron oxide paste (E172) Yellow iron oxide paste (E172) Titanium dioxide (E171) Lecithin Medium chain triglycerides
3 år.
Black ink
6. 4 Særlige opbevaringsforhold
Components of black printing ink.
EMEA/ CPMP/ 2811/ 03
Polyvinyl acetate phthalate Black iron oxide (E172) Macrogol 400 EMEA/ CPMP/ 2811/ 03 Propylene glycol Ammonium hydroxide (38%) >
21/ 22
21/ 22
Må ikke opbevares over 25° C.
6.4 Special precautions for storage
Hold beholderen tæt lukket for at beskytte mod lys.
Keep the container tightly closed to protect from light.
Termoform blisterpakning.
Thermoform blister.
Hver blisterstrimmel er formet i ugennemsigtigt triplex laminat (PVC/ PE/ PVdC) forseglet med aluminiumfolie.
Each blister strip is formed from opaque triplex laminate (PVC/ PE/ PVdC) sealed with aluminium lidding foil.
Pakkestørrelse på 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 & 180.
Pack sizes of 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168 & 180.
Alle pakkestørrelser forhandles muligvis ikke.
Not all pack sizes may be marketed.
6. 6 Instruktioner vedrørende håndtering og destruktion
6.6 Instructions for use and handling< and disposal >
Ingen specielle krav.
No special instructions.
Schering Health Care Ltd The Brow Burgess Hill West Sussex RH15 9NE England
Schering Health Care Ltd The Brow Burgess Hill West Sussex RH15 9NE England
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM( ER), STYRKE( R), INDGIVELSESVEJ( E), ANSØGER( E), INDEHAVER( E) AF MARKEDSFØRINGSTILLADELSE( R) I MEDLEMSSTATERNE
LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
GlaxoSmithKline Pharma GmbH, Albert- Schweitzer- Gasse 6, A- 1140 Wien, Østrig
GlaxoSmithKline Pharma GmbH, Albert-Schweitzer-Gasse 6 A-1140 Wien Austria
Dispergible tabletter
Dispersible Tablet
Rue du Tilleul 13, B86 1332 Genval Belgien
Rue du Tilleul 13, B86 1332 Genval Belgium
2 Belgien
2 Belgium
3 Belgien
Belgium
Belgien
3 Belgium
10 1408 Sofia Bulgarien
GlaxoSmithKline EOOD, Ivan Vazov complex Dimitar Manov street, bl.10, Sofia 1408 Bulgaria
4 Bulgarien
Bulgaria
10 1408 Sofia Bulgarien
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Cypern
4 Cyprus
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Storbritannien
Glaxo Group Ltd Berkeley Avenue Greenford Middlesex UB6 0NN United Kingdom
5 Cypern
Cyprus
25 mg
5 Czech Republic
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN Storbritannien
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN United Kingdom
6 Tjekkiet
Czech Republic
Tjekkiet
6 Czech Republic
7 Danmark
Denmark
GlaxoSmithKline Pharma A/ S Nykaer 68 DK- 2605 Broendby Danmark
GlaxoSmithKline Pharma A/ S Nykaer 68 DK-2605 Broendby Denmark
Danmark
7 Denmark
8 Danmark
Denmark
Danmark
8 Denmark
Glaxo Wellcome Operations Greenford Road Greenford Middlesex UB6 0NN Storbritannien
Glaxo Wellcome Operations Greenford Road Greenford Middlesex UB6 0NN United Kingdom
9 Estland
Estonia
Estland
9 Estonia
GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finland
GlaxoSmithKline Oy Piispansilta 9 A 02230 Espoo Finland
10 Finland
Finland
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly- le- Roi Cedex Frankrig
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
Lamicstart comprimé
Lamicstart
25 mg,
25 mg, comprimé
Frankrig
10 France
50 mg,
50 mg, comprimé 50 mg
Laboratoire GlaxoSmithKline
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
mg,
mg, comprimé dispersible 2 mg
Laboratoire GlaxoSmithKline 100 Route de Versailles
Laboratoire GlaxoSmithKline 100 Route de Versailles 78163 Marly-le-Roi Cedex France
Lamictal comprimé
Lamictal 5 croquer
5 mg, 5 mg dispersible
mg, comprimé dispersible ou à 5 mg
Dispergible eller tyggetabletter
Dispersible or chewable Tablet
Lamictal 25 mg, 25 mg comprimé dispersible ou à croquer
25 mg, comprimé dispersible ou à 25 mg
Lamictal 50 mg, 50 mg comprimé dispersible ou à croquer
50 mg, comprimé dispersible ou à 50 mg
Lamictal 100 mg, 100 mg comprimé dispersible ou à croquer
100 mg, comprimé dispersible ou à 100 mg
11 Frankrig
France
Lamictal comprimé
Lamictal croquer
200 mg, 200 mg dispersible
200 mg, comprimé dispersible ou à 200 mg
KG Theresienhöhe 11 80339 München Tyskland
Lamictal
Lamictal 2 mg 2 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
2 mg Tabletten zur Herstellung einer 2 mg
KG Theresienhöhe 11 80339 München Tyskland
KG Theresienhöhe 11 80339 München Germany
Lamictal 5 mg 5 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
Suspension zum Einnehmen
Tyskland
11 Germany
KG
GlaxoSmithKline GmbH & Co.
25 mg 25 mg
5 mg Tabletten zur Herstellung einer 5 mg
Theresienhöhe 11 80339 München Tyskland
KG Theresienhöhe 11 80339 München Germany
Tabletten zur Herstellung einer Suspension zum Einnehmen
Suspension zum Einnehmen
Lamictal 50 mg 50 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
Lamictal 25 mg Tabletten zur Herstellung einer 25 mg Suspension zum Einnehmen
Lamictal 100 mg 100 mg Tabletten zur Herstellung einer Suspension zum Einnehmen
Lamictal 50 mg Tabletten zur Herstellung einer 50 mg Suspension zum Einnehmen
12 Tyskland
Germany
KG
KG Theresienhöhe 11 80339 München Germany
Lamictal
Lamictal 100 mg Tabletten zur Herstellung einer 100 mg Suspension zum Einnehmen
Tabletten zur Herstellung einer Suspension zum Einnehmen
Lamictal 200 mg Tabletten zur Herstellung einer 200 mg Suspension zum Einnehmen
GlaxoSmithKline α. ε. β. ε 266 Kifissias Ave 152 32 Halandri Athens Grækenland
GlaxoSmithKline α .ε .β .ε 266 Kifissias Ave 152 32 Halandri Athens Greece
Lamictal
Lamictal 25 mg
Grækenland
12 Greece
Dispergible eller tyggetabletter
Dispersible/ Chewable Tablets
13 Grækenland
Greece
Grækenland
13 Greece
MOM Park, Gesztenyes torony Ungarn
MOM Park, Gesztenyes torony Hungary
14 Ungarn
Hungary
Ungarn
14 Hungary
GlaxoSmithKline ehf Thverholt 14 PO Box 5499 105 Reykjavik Island
Thverholt 14 105 Reykjavik Iceland
15 Island
Iceland
GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Irland
GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Ireland
Irland
15 Ireland
Tabletter
50 mg Tablet
Tabletter
200 mg Tablet
16 Irland
Ireland
Dispergible tabletter
2 mg Dispersible Tablet
Dispergible tabletter
5 mg Dispersible Tablet
Dispergible tabletter
25 mg Dispersible Tablet
Irland
16 Ireland
17 Italien
Italy
GlaxoSmithKline SpA Via Fleming 2 37135 Verona Italien
GlaxoSmithKline SpA Via Fleming 2 37135 Verona Italy
Italien
17 Italy
GlaxoSmithKline Letland SIA
GlaxoSmithKline Latvia SIA Bruninieku iela 5 Riga LV-1001 Latvia
2 mg
2 mg dispersible tablets
GlaxoSmithKline Letland SIA Bruninieku iela 5 Riga LV- 1001 Letland
GlaxoSmithKline Latvia SIA Bruninieku iela 5 Riga LV-1001 Latvia
Lamictal 5 mg 5 mg dispersible tablets
5 mg dispersible tablets
Lamictal 25 mg 25 mg dispersible tablets
25 mg dispersible tablets
18 Letland
Latvia
Lamictal 100 mg dispersible tablets
100 mg dispersible tablets
Lamictal 200 mg dispersible tablets
200 mg dispersible tablets
Litauen
18 Lithuania
19 Litauen
Lithuania
Litauen
19 Lithuania
20 Luxembourg
Luxembourg
Luxembourg
20 Luxembourg
21 Luxembourg
Luxembourg
Dispergible / tyggetablet Oral anvendelse
Dispersible / Chewable Tablet
Dispergible / tyggetablet Oral anvendelse
Oral use
25 mg
5 mg
Holland
Malta
GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist Holland
GlaxoSmithKline (Ireland) Ltd Stonemasons Way Rathfarnham Dublin 16 Ireland
Lamictal 2 Dispers
Lamictal
2 mg
25 mg
Dispergible tabletter Oral anvendelse
Oral use
GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist Holland
GlaxoSmithKline BV Huis ter Heideweg 62 3705 LZ Zeist The Netherlands
Lamictal 5 Dispers
Lamictal 2 Dispers
5 mg
2 mg
Lamictal 25 Dispers
Lamictal 5 Dispers
23 Holland
The Netherlands
GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N- 0319 Oslo Norge
GlaxoSmithKline AS Forskningsveien 2a Postbox 180 Vinderen N-0319 Oslo Norway
Norge
23 Norway
24 Norge
Norway
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS Storbritannien
GlaxoSmithKline Export Ltd 980 Great West Road Brentford Middlesex TW8 9GS United Kingdom
Polen
24 Poland
25 Polen
5 mg
António Loureiro Borges 3 Arquiparque - Miraflores 1495 - 131 Algés Portugal
António Loureiro Borges 3 Arquiparque - Miraflores 1495 - 131 Algés Portugal
26 Portugal
25 Portugal
27 Portugal
26 Portugal
28 Portugal
27 Portugal
Rumænien
28 Romania
Dispergible / tyggetabletter
Dispersible/ Chewable Tablet
29 Rumænien
Romania
GlaxoSmithKline Slovakiet s. r. o.
GlaxoSmithKline Slovakia s. r. o.
Galvaniho 7/ A 82104 Bratislava Slovakiet
Galvaniho 7/ A 82104 Bratislava Slovakia
Slovakiet
29 Slovakia
30 Slovakiet
Slovakia
Lamictal tablete
Lamictal
25 mg 25 mg
25 mg tablete 25 mg
50 mg 50 mg
50 mg tablete 50 mg
Slovenien
30 Slovenia
Lamictal tablete
100 mg tablete
Lamictal tablete
200 mg tablete
200 mg 200 mg
200 mg
31 Slovenien
Slovenia
disperzibilne/ žvečljive tablete
5 mg disperzibilne/ž več ljive tablete
tyggetabletter
Dispersible/ Chewable Tablet
Lamictal 25 mg 25 mg disperzibilne/ žvečljive tablete
25 mg disperzibilne/ž več ljive tablete
Lamictal 50 mg 50 mg disperzibilne/ žvečljive tablete
50 mg disperzibilne/ž več ljive tablete
Lamictal 100 mg 100 mg disperzibilne/ žvečljive tablete
100 mg disperzibilne/ž več ljive tablete
Lamictal 200 mg 200 mg disperzibilne/ žvečljive tablete
200 mg disperzibilne/ž več ljive tablete
GlaxoSmithKline S. A Severo Ochoa 2 28760 Tres Cantos Madrid Spanien
GlaxoSmithKline S. A Severo Ochoa 2 28760 Tres Cantos Madrid Spain
Spanien
31 Spain
32 Spanien
Spain
Sverige
32 Sweden
GlaxoSmithKline AB Box 516 169 29 Solna Sverige
GlaxoSmithKline AB Box 516 169 29 Solna Sweden
33 Sverige
Sweden
Opløselige tabletter
Soluble Tablet
Sverige
33 Sweden
34 Sverige
Sweden
Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Storbritannien
Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom
35 Storbritannien
34 United Kingdom
36 Storbritannien
36 United Kingdom
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN UK Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Storbritannien
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN United Kingdom
200 mg
5 mg
Tabletter
Dispersible Tablet
37 Storbritannien
37 United Kingdom
5 mg
50 mg
25 mg
100 mg
38 Storbritannien
38 United Kingdom
50 mg
200 mg
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN UK Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Storbritannien
Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT United Kingdom
39 Storbritannien
39 ANNEX II
The Wellcome Foundation Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN UK Trading as GlaxoSmithKline UK Stockley Park West Uxbridge Middlesex UB11 1BT Storbritannien
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
40 BILAG II
40 SCIENTIFIC CONCLUSIONS
Lamotrigin (det aktive stof i Lamictal) er et velkendt antiepileptikum, der i de fleste EU - medlemsstater er godkendt nationalt til behandling af epileptiske anfald.
Lamotrigine (the active substance of Lamictal) is a well-known anti-epileptic agent approved for the treatment of epileptic seizures in most EU-member states on a National basis.
Desuden er Lamictal godkendt til behandling af patienter med bipolar lidelse i en række EU- medlemsstater bortset fra Det Forenede Kongerige, Nederlandene, Frankrig og Cypern.
In addition Lamictal has been approved for use in bipolar patients in several EU member states except in the UK, Netherlands, France and Cyprus.
Bortset fra indikationen bipolare lidelser er der store overlapninger i produktresuméerne for Lamictal i de forskellige EU- medlemsstater.
Apart from the indication in bipolar disorder the SPC of Lamictal in the different EU members show a large overlap.
Indehaverne af markedsføringstilladelsen har derfor indledt en artikel 30- procedure (i henhold til Rådets direktiv 2001/ 83/ EØF) med henblik på harmonisering af produktresuméerne for lamotrigin i hele Europa.
Hence an article 30 procedure (Directive 2001/ 83/ EC) for harmonisation of the SPC of lamotrigine across Europe has been initiated by the Marketing Authorisation Holder.
Denne indbringelse skyldes betænkeligheder vedrørende EU- medlemsstaternes divergerende beslutninger med hensyn til godkendelsen af indikationen bipolar lidelse for lamotrigin.
This referral is undertaken following concerns related to divergent decisions on approval of the bipolar indication for lamotrigine across EU Member States.
Desuden har vurderingen af kvalitetsspørgsmål ført til en harmonisering af lægemiddelformerne (tablet og dispergibel tablet/ tyggetablet) i EU.
In addition, the assessment of quality issues has led to the harmonisation of the pharmaceutical forms (tablet and dispersible/ chewable tablet) across the EU.
Terapeutiske indikationer (afsnit 4. 1 i produktresuméet)
Therapeutic Indications (SPC section 4.1)
“ Voksne og børn over 12 år {Handelsnavn} er indiceret som monoterapi eller tillægsbehandling af epilepsi med partielle anfald og generaliserede anfald, herunder tonisk- kloniske anfald og anfald ved Lennox- Gastaut syndrom ”.
“ Adults and children above 12 years {Tradename} is indicated for use as adjunctive or monotherapy in the treatment of epilepsy, for partial seizures and generalised seizures, including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
Monoterapi ved behandling af Lennox- Gastaut syndrom er sjældent mulig, da der normalt kræves mere end ét lægemiddel til at opnå kontrol med symptomerne.
Monotherapy in Lennox-Gastaut Syndrome is rarely achievable, as usually more than one medicinal product is needed to control the symptoms.
I indikationen vil den angivne målpopulation være “ Voksne og unge på 13 år og derover ”.
The indication will specify that the target population is “ Adults and adolescents aged 13 years and above”.
“ Børn på 2 til 12 år {Handelsnavn} er indiceret som tillægsbehandling af epilepsi med partielle anfald og generaliserede anfald, herunder tonisk- kloniske anfald og anfald ved Lennox- Gastaut syndrom ”.
“ Children 2 to 12 years {Tradename} is indicated as adjunctive therapy in the treatment of epilepsy, for partial seizures and generalised seizures including tonic-clonic seizures and the seizures associated with Lennox-Gastaut Syndrome”.
I indikationen vil det blive angivet, at målpopulationen er “ Børn og unge på 2 til 12 år ”.
The indication will specify that the target population is “ Children and adolescents aged 2 to 12 years“.
“ Når der er opnået kontrol med epilepsien ved hjælp af tillægsbehandlingen, kan brugen af andre antiepileptika ophøre, og patienten kan fortsætte med {Handelsnavn} som monoterapi ”.
“ After epileptic control has been achieved during adjunctive therapy, concomitant antiepileptic drugs (AEDs) may be withdrawn and patients continued on {Tradename} monotherapy”.
Denne tekst bør derfor flyttes til afsnit 4. 2 om dosering og indgivelsesmåde.
This text should be therefore moved to section 4.2, Posology and method of administration.
42 Bipolar lidelse
41 Bipolar disorder
“ Voksne på 18 år og derover {Handelsnavn} er indiceret til forebyggelse af humørsvingninger hos patienter med bipolar lidelse, hovedsagelig ved forebyggelse af depressive episoder ”.
“ Adults 18 years and above {Tradename} is indicated for the prevention of mood episodes in patients with bipolar disorder, predominantly by preventing depressive episodes”.
Målpopulationen vil være bipolar I- patienter, da de kliniske undersøgelser omfattede disse patienter.
The target population will be Bipolar I patients, as these patients were included in the clinical studies.
Det bekræftes, at risk/ benefit- forholdet er gunstigt ved tillægsbehandling af partielle og generaliserede anfald hos voksne og unge på 13 år og derover.
The benefit/ risk ratio of adjunctive treatment of partial and generalised seizures in adults and adolescents aged 13 years and above, was confirmed to be positive.
Selv om indehaveren af markedsføringstilladelsen ikke har gennemført specifikke undersøgelser med lamotrigin- monoterapi udelukkende hos patienter med primære generaliserede tonisk- kloniske anfald, bekræfter data fra kontrollerede initiale monoterapi- undersøgelser (undersøgelse UK49/ 89 og UK74) lamotrigins virkning på disse anfaldstyper.
Although the Marketing Authorisation Holder has not conducted specific studies with lamotrigine monotherapy solely in patients with primary generalised tonic clonic seizures, data from controlled initial monotherapy studies (studies UK49/ 89, UK74) reassure on the efficacy of lamotrigine on this seizure types.
Risk/ benefit- forholdet for lamotrigin ved tillægsbehandling af primære generaliserede tonisk- kloniske anfald hos børn anses også for at være gunstigt.
The benefit/ risk of lamotrigine as add-on treatment in primary generalised tonic clonic seizures in children is also considered favourable.
Lennox- Gastaut syndrom er vanskelig at behandle, og monoterapi er sjældent mulig.
Lennox-Gastaut Syndrome is a difficult to treat condition and monotherapy is rarely achieved.
De analyserede data udelukker ikke, at lamotrigin kan anvendes som indledende behandling.
There is no consensus on which drug should be used as initial treatment; however, the data analysed do not exclude that lamotrigine could be the initial agent.
Om virkningen kan fastholdes ved de typiske absenceanfald, er fortsat uklar, og der vil derfor blive indsat en advarsel i produktresuméet, der påpeger, at “ Hos børn, der får lamotrigin til behandling af typiske absenceanfald, kan virkningen muligvis ikke fastholdes hos alle patienter ”.
The maintenance effect on typical absence seizures remains unclear, thus a warning will be included in the SPC stating that “ In children taking lamotrigine for the treament of typical absence seizures, efficacy may not be maintained in all patients”.
Desuden havde de undersøgte patienter diagnosen bipolar I- lidelse, hvorfor resultaterne af disse undersøgelser ikke nødvendigvis kan overføres på bipolar II- lidelse.
In addition, the patients studied were diagnosed with Bipolar I disorder; therefore the results of these studies may not be extrapolated to Bipolar II disorder.
43 CHMP konsulterede desuden en videnskabelig rådgivende gruppe vedrørende CNS med henblik på rådgivning vedrørende bipolar lidelse og behandling heraf.
42 A CNS Scientific Advisory Group (SAG) was also consulted to advise the CHMP on Bipolar disorder and its treatment.
CHMP konkluderede i betragtning af vurderingen af undersøgelserne og anbefalingerne fra den videnskabelige rådgivende gruppe, at lamotrigin bør anvendes til forebyggelse af depressive episoder hos patienter med bipolar I- lidelse, som overvejende oplever depressive episoder.
The CHMP, taking into consideration the assessment of the studies and the recommendation of the SAG concluded that lamotrigine should be used for the prevention of depressive episode in patients with Bipolar I disorder who experience predominantly depressive episodes.
Eftersom:
Whereas
- formålet med indbringelsen af sagen var at harmonisere produktresuméerne, etiketteringen og
- The scope of the referral was the harmonisation of the Summaries of Products Characteristics,
indlægssedlen,
labelling and package leaflet.
- de produktresuméer og den etikettering og indlægsseddel, der er foreslået af indehaverne af
- The Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
markedsføringstilladelsen, er vurderet på baggrund af den indsendte dokumentation og udvalgets videnskabelige drøftelse,
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee
” Epilepsi
“ Epilepsy
Voksne og unge på 13 år og derover
Adults and adolescents aged 13 years and above
- Tillægsbehandling eller monoterapi ved partielle anfald og generaliserede anfald, herunder
- Adjunctive or monotherapy treatment of partial seizures and generalised seizures, including
tonisk- kloniske anfald.
tonic-clonic seizures.
- Anfald ved Lennox- Gastaut syndrom.
- Seizures associated with Lennox-Gastaut syndrome.
Lamictal gives som tillægsbehandling, men kan også
Lamictal is given as adjunctive therapy
være det antiepileptikum, som en behandling af Lennox- Gastaut syndrom indledes med.
but may be the initial antiepileptic drug (AED) to start with in Lennox-Gastaut syndrome.
Børn og unge på 2 til 12 år
Children and adolescents aged 2 to 12 years
- Tillægsbehandling af partielle anfald og generaliserede anfald, herunder tonisk- kloniske
- Adjunctive treatment of partial seizures and generalised seizures, including tonic-clonic
anfald og anfald ved Lennox- Gastaut syndrom.
seizures and the seizures associated with Lennox-Gastaut syndrome.
- Monoterapi- behandling af typiske absenceanfald.
- Monotherapy of typical absence seizures.
- Forebyggelse af depressive episoder hos patienter med bipolar I- lidelse, som overvejende
- Prevention of depressive episodes in patients with bipolar I disorder who experience
oplever depressive episoder (se afsnit 5. 1).
predominantly depressive episodes (see section 5.1).
Lamictal er ikke indiceret til akut behandling af maniske eller depressive episoder ”.
Lamictal is not indicated for the acute treatment of manic or depressive episodes”.
44 CHMP anbefalede ændring af markedsføringstilladelsen / - erne for Lamictal og tilknyttede navne (se bilag I), for hvilke produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III.
44 ANNEX III
45 BILAG III
45 SUMMARY OF PRODUCT CHARACTERISTICS
46 PRODUKTRESUME
46 1.
Lamictal og tilknyttede navne (se bilag I) 5 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 2 mg dispersible/ chewable tablets.
Lamictal og tilknyttede navne (se bilag I) 25 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 5 mg dispersible/ chewable tablets.
Lamictal og tilknyttede navne (se bilag I) 50 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 50 mg dispersible/ chewable tablets.
Lamictal og tilknyttede navne (se bilag I) 100 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 100 mg dispersible/ chewable tablets.
Lamictal og tilknyttede navne (se bilag I) 200 mg dispergible tabletter / tyggetabletter.
Lamictal and associated names (see Annex I) 200 mg dispersible/ chewable tablets.
[Se bilag I – udfyldes nationalt]
[See Annex I - To be completed nationally]
Hver tablet indeholder 23, 5 mg lactose.
Each tablet contains 23.5 mg lactose.
Hver tablet indeholder 46, 9 mg lactose.
Each tablet contains 46.9 mg lactose.
Hver tablet indeholder 93, 9 mg lactose.
Each tablet contains 93.9 mg lactose.
Hver tablet indeholder 109, 0 mg lactose.
Each tablet contains 109.0 mg lactose.
Hver Lamictal 5 mg dispergibel tablet / tyggetabletindeholder 5 mg lamotrigin.
Each Lamictal 2 mg dispersible/ chewable tablet contains 2 mg lamotrigine.
Hver Lamictal 25 mg dispergibel tablet / tyggetabletindeholder 25 mg lamotrigin.
Each Lamictal 5 mg dispersible/ chewable tablet contains 5 mg lamotrigine.
Hver Lamictal 50 mg dispergibel tablet / tyggetabletindeholder 50 mg lamotrigin.
Each Lamictal 50 mg dispersible/ chewable tablet contains 50 mg lamotrigine.