The Summary of Product Characteristics (SPC) is a specific document, the wording of which has been agreed with the regulatory authority as part of the medicine approval process. It is required before any medicine is allowed on the market in Europe. It is designed to assist doctors and pharmacists in prescribing and supplying the product.
''Company'' may refer to either the Marketing Authorization Holder (MAH), the company responsible for marketing the product in Ireland and/or responsible for uploading documents pertaining to the product onto Medicines.ie. To determine the MAH, please consult the actual submitted documents.
