Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1041309
Name of medicinal product: SANDOSTATIN LAR
Active substances:
Estonian, English, Latin
ATC code: H01CB02
Dosage form: powder and solvent for suspension for injection
Route of administration: intramuscular use
Strengh: 10mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: Treatment of patients with acromegaly in whom surgery is inappropriate or ineffective, or in the interim period until radiotherapy becomes fully effective (see section 4.2). Treatment of patients with symptoms associated with functional gastro-entero-pancreatic endocreatic tumours e.g. carcinoid tumours with features of the carcinoid syndrome (see section 5.1). Treatment of patients with advanced neurorndocrine tumours of the midgut or of unknown 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated September 27, 2022)
Package information leaflet (PIL): EST  (last updated February 15, 2024)
Labelling:  (last updated August 15, 2022)
Last imported to Estonia: May 23, 2024
Marketing authorization holder: Novartis Baltics SIA 
Marketing authorization number: 283099 
Marketing authorization issued on: October 28, 1999 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Mutual recognition 
Percent Valid from Valid until Valid Diagnosis Doctor's speciality Primary Age Other
100  05.04.2024     Yes  C00-D48; E22.0-E22.0  Endokrinoloog, Pediaater – endokrinoloog, Onkoloog  No  until 4 years  neuroendokriinkasvaja või akromegaalia raviks 
100  05.04.2024     Yes  C00-D48; E22.0-E22.0  Onkoloog, Pediaater – endokrinoloog, Endokrinoloog  No     neuroendokriinkasvaja või akromegaalia raviks 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 3, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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