The Main Pharmaceutical Inspectorate issued a decision to withdraw the series of Thiogamma from the market. It is a drug used by diabetics. The decision is immediately enforceable.
Withdrawal of Thiogamma
The Main Pharmaceutical Inspectorate, at the request of the MAH, made a decision to withdraw the batch of Thiogamma from the market. The reason is that the result is out of specification for the parameter “decay”. Such a quality defect qualifies the product for withdrawal from the market.
A batch of Thiogamma that has been withdrawn from the market:
- batch number: 15E138, expiry date 04.2020
Use of Thiogamma
Thiogamma is used to treat sensory disturbances in diabetic polyneuropathy. The active substance is alpha-lipoic acid. It is not recommended to administer this preparation to people under 18 years of age. It should be taken under close medical supervision as it may increase the effect of antidiabetic drugs.
Thiogamma is a prescription-only medicine.