Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1755615
Name of medicinal product: OCTREOTIDE TEVA
Active substances:
Octreotide
Estonian, English, Latin
ATC code: H01CB02
Dosage form: powder and solvent for prolonged-release suspension for injection
Route of administration: intramuscular use
Strengh: 30mg
Amount in package: 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: lahusti 2 ml
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 endocrine tumours e.g. carcinoid tumours with features of the carcinoid system (see section 5.1). 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.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated February 26, 2024)
Package information leaflet (PIL): EST  (last updated May 5, 2023)
Labelling:  (last updated August 18, 2022)
Last imported to Estonia: December 22, 2021
Marketing authorization holder: Teva B.V. 
Marketing authorization number: 988719 
Marketing authorization issued on: June 3, 2019 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: June 11, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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