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Pharmaceuticals - Community Register


List of nationally authorised medicinal products for human use

Sandostatin and associated names

Product name: Sandostatin and associated names
Active substance: octreotide
Indication: • Symptomatic control and reduction of growth hormone (GH) and IGF-1 plasma levels in patients with acromegaly who are inadequately controlled by surgery or radiotherapy
• Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumours
• Prevention of complications following pancreatic surgery
• Emergency management to stop bleeding and to protect from re bleeding owing to gastro oesophageal varices in patients with cirrhosis
• Treatment of TSH-secreting pituitary adenomas
- when secretion has not normalised after surgery and/or radiotherapy;
- in patients in whom surgery is inappropriate;
- in irradiated patients, until radiotherapy is effective
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
28/08/2014 Referral EMEA/H/A-30/1354 (2014)6186 of 26/08/2014