Get Stamaril - Annexes I-ii-iii-en - Ema Europa

The medicine, or the class of medicines, is 'referred' to the European Medicines Agency, so that it can make a recommendation for a harmonised position across the European Union ( EU ). Referrals can be started by the European Commission, any Member State or by the company that markets the medicine.

The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency (EMEA).

The European regulatory system for medicines monitors the safety of all medicines that are available on the European market throughout their life span. EMA has a committee dedicated to the safety of medicines for human use — the Pharmacovigilance Risk Assessment Committee, or PRAC.

Clinical trials are intended to prove the efficacy of new medicinal products and to demonstrate their safety. Clinical trials are performed before the product concerned is placed on the market and they have to be approved in Germany by the respective competent federal higher authority.

Our Medicine finder above helps you find information on medicines authorised for human or veterinary use. You can find these by including the medicine's name or its active substance. It shows you information on centrally authorised medicines - medicines that EMA evaluated.

After the evaluation, the CHMP issues a scientific opinion on whether the medicine may be authorised or not. EMA sends this opinion to the European Commission, which issues the marketing authorisation. EMA then publishes a summary of the committee's opinion.

The CE Mark in the European Union and the FDA approval process in the United States both perform the same functions, namely assessing the safety and efficacy of new devices. Despite the differences in the CE Mark and FDA approval systems, there are no more product recalls in Europe than in the United States.

Pseudoephedrine-containing medicines are authorised in various EU Member States and are used alone or in combination with other medicines to treat symptoms of cold and flu, such as headache, fever and pain, allergic rhinitis (inflammation of the nasal passages from allergies) or vasomotor rhinitis (inflammation of the ...