Due to the insufficiently demonstrated efficacy in some indications from the range of painful muscular tension and in view of the risk of allergic reactions, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommends a restriction of the indications to post-stroke spasticity in adults.

risk information - full text (available in German only)

Graduatet plan procedure (Stufenplanverfahren) on tolperisone (available in German only)