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Czech regulator moves Zentiva's erdostein 300 mg capsules from prescription-only to over-the-counter supply

🇨🇿 SÚKL · Tue 10 Nov 2026

SÚKL says Erdostein Zentiva 300 mg hard capsules can be dispensed without a prescription from 29 October 2026, though the product is not yet marketed in the Czech Republic.

The State Institute for Drug Control (SÚKL) has announced a change to the method of supply of Erdostein Zentiva 300 mg hard capsules. From 29 October 2026, the product moves from prescription-only dispensing to dispensing without a medical prescription. The notice was published on 10 November 2026 and is addressed to healthcare professionals and patients.

The product carries registration number 52/353/25-C and SÚKL code 287505. SÚKL stresses that it is not currently distributed, dispensed or used in Czech healthcare. According to the latest information from the marketing authorisation holder, it is expected to launch as a non-prescription medicine around the middle of 2027.

The capsules are used in adults to treat acute upper and lower respiratory tract infections with mucus production and a productive (wet) cough. SÚKL notes that the change will widen non-prescription access to erdostein in both strength and form. Until now, only erdostein 225 mg granules for oral suspension were available over the counter in the Czech Republic.

Once the product is on the market, patients will be able to buy the 300 mg capsules in pharmacies without a prescription. The capsule is swallowed whole with water, whereas the existing granules are dissolved in liquid and drunk as a suspension.

What it means for your team

  • Regulatory teams should note the legal supply status for registration 52/353/25-C is already non-prescription, even though no product is on the Czech market yet.
  • Market-access and commercial teams: the holder's indicated launch window is around mid-2027, and the product will enter as an OTC option with a higher strength and a new form than existing OTC erdostein.
  • Pharmacovigilance and labelling teams may need to consider how OTC availability affects patient information and reporting of adverse reactions once the product launches.

Official source: SÚKL ↗

Article written by VigiEye from the official source (SÚKL). AI-assisted; check the source before acting.

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