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List of referrals for human medicinal products

Sandostatin LAR and associated names

Product name: Sandostatin LAR and associated names
INN: octreotide
Indication: • Treatment of patients with acromegaly in whom surgery is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective
• Treatment of patients with symptoms associated with functional gastro entero pancreatic endocrine tumours
• Treatment of patients with advanced neuroendocrine tumours of the midgut or of unknown primary origin where non-midgut sites of origin have been excluded
• 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-30/1355 (2014)6185 of 26/08/2014