When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Application Type: 2010 - National Variation Type II (60 day)
Case Description: Somatuline LA 30mg Powder & solvent for suspension for injection -
C.I.Z Update of the product information (sections 1, 3, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1,5.2, 5.3, 6.4, 6.5 & 6.6)