The marketing authorization holder has informed its supplied customers in a letter dated June 21, 2017, that in the course of stability tests a trend towards a decrease of the active ingredient "Ambroxol hydrochloride" towards the end of the term has…

Cilag Pharma GmbH, AT-1020 Wien 1403842 6/4/13 Einstimmig Bescheid Zulassungsverlängerung national Mucosolvan 15 mg / 5 ml - Saft für Kinder 1-17347 Boehringer Ingelheim RCV GmbH & Co KG 1403839 6/4/13 Einstimmig [...] DHU-Arzneimittel GmbH & Co KG 1403713 6/4/13 Einstimmig Bescheid Zulassungsverlängerung national Mucosolvan 30 mg/5 ml - Saft 1-19598 Boehringer Ingelheim RCV GmbH & Co KG 1403690 6/4/13 Einstimmig Bescheid [...] nach § 10 (GENA) Ambroxol "Aponova" 60 mg - Brausetabletten 1-31847 Aponova Pharma Handels GmbH Mucosolvan 60 mg - Brausetabletten 1360804 3/15/13 Einstimmig Bescheid Zulassung nach § 09b (H) Colocynth

Referenced at:

• BASG approval procedure