Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1753219
Name of medicinal product: SIGNIFOR
Active substances:
Estonian, English, Latin
ATC code: H01CB05
Dosage form: powder and solvent for 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 süstlis 1 TK
Indication: Treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with another somatostatin analogue. Treatment of adult patients with Cushing’s disease for whom surgery is not an option or for whom surgery has failed. The 60 mg strength is only to be used in the treatment of acromegaly.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Recordati Rare Diseases 
Marketing authorization number: EU/1/12/753 
Marketing authorization issued on: September 18, 2017 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: May 29, 2020
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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