Product

Isosorbide-5-Mononitrate

Pharmaceutical Form

Tablets

Strengths

25 mg, 30 mg, 40 mg, 50 mg and 60 mg

Release Characteristics

Sustained Release (like Astra’s – UK – IMDUR DURULES tablets)

Posology

Once / twice daily

Raw Material

DMF available

Chemical Pharmaceutical Dossier

Available in CTD format

Parmacokinetics

Single dose, two-way bioequiva-lence study vs. IMDUR 60 mg Retard Tablets (Astra, UK) on 24 healthy volunteers. Multiple dose, two-way bioequiva-lence study vs. IMDUR 60 mg Retard Tablets (Astra, UK) on 24 healthy volunteers. Single dose, three-way, fasting/ non-fasting bioequivalence study vs. IMDUR 60 mg Retard Tablets (As-tra, UK) on 24 healthy volunteers.

Registration underway

Greece, Portugal, Spain

Marketing

Croatia, Denmark, Georgia, Iceland, Italy, Romania, Republic of South Africa, Russia, Slovenia, The Nether-lands, United Kingdom, Uzbekistan.

Notes

Free Sale Certificate available