Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1875326
Name of medicinal product: SANDOSTATIN
Active substances:
Estonian, English, Latin
ATC code: H01CB02
Dosage form: solution for injection/infusion
Route of administration: subcutaneous use
Strengh: 0,1mg 1ml
Amount in package: 1ml 20TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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. Sandostatin is also indicated for acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. Relief of symptoms associated with functional gastro-entero-pancreatic (GEP) endocrine tumours, e.g. carcinoid tumours with features of the carcinoid syndrome (see section 5.1). Sandostatin is not an anti-tumour therapy and is not curative in these patients. 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. Sandostatin is to be used in association with specific treatment such as endoscopic sclerotherapy. 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated February 15, 2024)
Package information leaflet (PIL): EST  (last updated February 15, 2024)
Labelling:  (last updated August 15, 2022)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Novartis Baltics SIA 
Marketing authorization number: 217498 
Marketing authorization issued on: September 4, 1998 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: March 21, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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