Qual a composição de Slenyto
Dose de 1 mg
-
A substância ativa é a melatonina. Cada comprimido contém 1 mg de melatonina.
-
Os outros componentes são o copolímero tipo B do metacrilato de amónio, hidrogenofosfato de cálcio di-hidratado, lactose mono-hidratada, sílica (coloidal anidra), talco, estearato de magnésio, carmelose sódica (E466), maltodextrina, glucose mono-hidratada, lecitina (E322), dióxido de titânio (E171), óxido de ferro vermelho (E172) e óxido de ferro amarelo (E172).
Dose de 5 mg
-
A substância ativa é a melatonina. Cada comprimido contém 5 mg de melatonina.
-
Os outros componentes são o copolímero tipo A do metacrilato de amónio, hidrogenofosfato de cálcio di-hidratado, lactose mono-hidratada, sílica (coloidal anidra), estearato de magnésio, carmelose sódica (E466), maltodextrina, glucose mono-hidratada, lecitina (E322), dióxido de titânio (E171) e óxido de ferro amarelo (E172).
Qual o aspeto de Slenyto e conteúdo da embalagem
Dose de 1 mg
Slenyto 1 mg comprimido de libertação prolongada está disponível na forma de comprimidos revestidos por película, redondos, biconvexos, rosa com 3 mm de diâmetro.
Está disponível em embalagens blisters de 30/60 comprimidos.
Dose de 5 mg
Slenyto 5 mg comprimido de libertação prolongada está disponível na forma de comprimidos revestidos por película, redondos, biconvexos, amarelos com 3 mm de diâmetro.
Está disponível em embalagens blisters de 30 comprimidos.
É possível que não sejam comercializadas todas as apresentações.
Titular da Autorização de Introdução no Mercado
RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux
75002 Paris França
e-mail: regulatory@neurim.com
Fabricante
Iberfar - Indústria Farmacêutica, S.A.
Rua Consiglieri Pedrosa, n.° 121-123 Queluz de Baixo Barcarena
2734-501 Portugal
Para quaisquer informações sobre este medicamento, queira contactar o representante local do Titular da Autorização de Introdução no Mercado:
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
België/Belgique/Belgien | Lietuva |
RAD Neurim Pharmaceuticals EEC SARL | RAD Neurim Pharmaceuticals EEC SARL |
Tél/Tel: +33 185149776 (FR) | Tel: +33 185149776 (FR) |
e-mail: neurim@neurim.com | e-mail: neurim@neurim.com |
Ebjraphs | Luxembourg/Luxemburg |
RAD Neurim Pharmaceuticals EEC SARL TeJ. +33 185149776 (FR) e-mail: neurim@neurim.com | RAD Neurim Pharmaceuticals EEC SARL Tél/Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Ceská republika RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Magyarország RAD Neurim Pharmaceuticals EEC SARL Tel.: 185149776 (FR) e-mail: n eurim@neurim.com |
Danmark Takeda Pharma A/S Tlf: +45 46 77 11 11 | Malta RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Deutschland INFECTOPHARM Arzneimittel und Consilium GmbH Tel: +49 6252 957000 e-mail: kontakt@infectopharm.com | Nederland RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
Eesti RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com | Norge Takeda AS Tlf: +47 6676 3030 e-mail: infonorge@takeda.com |
RAD Neurim Pharmaceuticals EEC SARL Tnt: +33 185149776 (FR) e-mail: neurim@neurim.com | Österreich RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (FR) e-mail: neurim@neurim.com |
España
EXELTIS HEALTHCARE, S.L. Tel: +34 91 7711500
e-mail: comunicación@exeltis.com
France
BIOCODEX
Tél: +33 (0)1 41 24 30 00 e-mail: medinfo@biocodex.com
Hrvatska
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Ireland
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Ísland
Williams & Halls ehf. Sími: +354 527 0600 Netfang: info@wh.is
Italia
Fidia Farmaceutici S.p.A. Tel: +39 049 8232222 e-mail: info@fidiapharma.it
Κύπρος
RAD Neurim Pharmaceuticals EEC SARL Τηλ: +33 185149776 (F)
e-mail: neurim@neurim.com
Latvija
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Polska
RAD Neurim Pharmaceuticals EEC SARL Tel.: +33 185149776 (F)
e-mail: neurim@neurim.com
Portugal
Laboratórios Azevedos – Indústria Farmacêutica, S.A.
Tel: +351 214 725 900 e-mail: mail@azevedos-sa.pt
România
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Slovenija
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Slovenská republika
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Suomi/Finland
Biocodex Oy
Puh/Tel: +3589 329 59100 e-mail: info@biocodex.fi
Sverige
Takeda Pharma AB
Tel: +46 8 731 28 00
e-mail: infosweden@takeda.com
United Kingdom (Northern Ireland)
RAD Neurim Pharmaceuticals EEC SARL Tel: +33 185149776 (F)
e-mail: neurim@neurim.com
Este folheto foi revisto pela última vez em { mês de AAAA}.
Outras fontes de informação
Está disponível informação pormenorizada sobre este medicamento no sítio da internet da Agência Europeia de Medicamentos: http://www.ema.europa.eu