To the attention of healthcare professionals, patients and citizens
|Information for medical specialists|
The Pharmacovigilance Risk Assessment Committee (PRAC) gave a recommendation on one safety review at its April meeting.
PRAC recommends against combined use of medicines affecting the renin-angiotensin (RAS) system
The PRAC has advised that the combined use of medicines of different classes acting on the renin-angiotensin (RAS) system, a hormone system that controls blood pressure and the volume of fluids in the body, should not be recommended. The affected medicines (called RAS-acting agents) are used particularly in the treatment of hypertension (high blood pressure) and congestive heart failure (a type of heart disease where the heart cannot pump enough blood around the body).
The PRAC recommendation will now be forwarded to the Committee for Medicinal Products for Human Use (CHMP) which will adopt the Agency’s final opinion.
More information is provided in the following hyperlink:
To the attention of all Marketing Authorisation Holders
Dear Marketing Authorisation Holders,
In accordance with the entry into force of the new European legislation regarding pharmacovigilance of medicinal products for human use, the Bulgarian Drug Agency (BDA) notifies Marketing Authorisation Holders (MAHs) for all medicinal products authorised/registered in Bulgaria, on the following temporary reporting requirements of the information on adverse drug reaction (ADR) in E2B format during the transitional period (until 6 months after the technical functionality of the database of the European Medicines Agency (EMA) - EudraVigilance has been declared):