What Diacomit 250 mg contains
? The active substance is stiripentol. Each sachet contains 250 mg of stiripentol. ? The other ingredients in this medicine are povidone K29/32, sodium starch glycolate type A, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
What Diacomit 500 mg contains
? The active substance is stiripentol. Each sachet contains 500 mg of stiripentol. ? The other ingredients in this medicine are povidone K29/32, sodium starch glycolate type A, glucose liquid (spray dried), erythrosine (E127), titanium dioxide (E171), aspartame (E951), tutti frutti flavour (contains sorbitol), carmellose sodium, hydroxyethylcellulose.
What Diacomit 250 mg looks like and contents of the pack
This medicine is a pale pink powder supplied in sachets.
Cartons contain either 30, 60, or 90 sachets. Not all pack sizes may be marketed. Diacomit is also available as 250 mg and 500 mg capsules for oral use and 500 mg powder for oral suspension in sachets.
What Diacomit 500 mg looks like and contents of the pack
This medicine is a pale pink powder supplied in sachets.
Cartons contain either 30, 60, or 90 sachets. Not all pack sizes may be marketed. Diacomit is also available as 250 mg and 500 mg capsules for oral use and 250 mg powder for oral suspension in sachets.
Marketing Authorisation Holder
Biocodex
7 avenue Gallieni - 94250 Gentilly - France
Tel: + 33 1 41 24 30 00 - e-mail: webar@biocodex.fr
Manufacturer
Biocodex
1 avenue Blaise Pascal - F-60000 Beauvais - France
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AT/BE/BG/CZ/CY/EE/EL/ES/FR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/RO/SI/SK/UK Biocodex
7 avenue Gallieni - F-94250 Gentilly
Tél/Tel.: + 33 (0)1 41 24 30 00
e-mail: webar@biocodex.fr
DE
Desitin Arzneimittel GmbH
Weg beim Jäger 214
D-22335 Hamburg
Tel: +49 (0)40 59101 525
e-mail: epi.info@desitin.de
DK
Desitin Pharma AS
Havnegade 55, st. tv.
1058 Kopenhagen K
Denmark
Tel: 0045-33-73 00 73
e-mail: desitin@desitin.dk
NO
Desitin Pharma AS
Niels Leuchs vei 99
1359 Eiksmarka
Norway
Tel: 0047 67 15 92 30
e-mail: firmapost@desitin.no
FI/SE
Desitin Pharma AB
Krokslätts Torg 5
43137 Mölndal
Sweden
Tel: 0046-31-20 23 10
e-mail: info@desitin.se
This leaflet was last approved in
This medicine has been given ?conditional approval?. This means that there is more definitive evidence to come about this medicine for the treatment of this form of epilepsy when stiripentol is used in conjunction with clobazam and valproate. The European Medicines Agency (EMA) will review new information on the medicine every year and this leaflet will be updated as necessary.
Detailed information on this medicine is available on the European Medicine Agency (EMA) website: http://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.
12 Areas Quality, Non-clinical, Clinical, Pharmacovigilance Due date for the follow-up measure or for the first interim report if a precise date cannot be committed t