Saroten Retard
Replacement
|
Medicines
|
23/01/2014
The marketing authorization holder informed its supplied customers in a letter dated 23.01.2014 that the batches listed show deviations in dissolution. The release of the active ingredient amitriptyline after four hours is slightly higher than intended.
| Name of the medicinal product | 1. Saroten Retard 25 mg - Kapseln 2. Saroten Retard 50 mg - Kapseln |
|---|---|
| Marketing authorisation number(s) | 1. 15.089 2. 15.984 |
| Marketing authorisation holder | Lundbeck Austria GmbH |
| Batch number(s) | 1. 2338796, 2338104 2. 2335801 |
| Classification of the recall | 2 |
| BASG reference number | INS - 640.001 - 0994 |
Further inquiry note
Page last modified:
12/07/2022