Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1792368
Name of medicinal product: OLFEN
Active substances:
Diclofenac
Estonian, English, Latin
ATC code: M02AA15
Dosage form: gel
Route of administration: cutaneous use
Strengh: 23,2mg 1g
Amount in package: 50g 1TK
Legal status for supply*: Not subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For adults and adolescents aged 14 years and over For local symptomatic treatment of pain in acute strains, sprains or contusions following blunt trauma. For adolescents aged 14 years and over the medicinal product is intended for short term treatment.
Safety features: No
Summary of product characteristics (SPC):  (last updated September 1, 2020)
Package information leaflet (PIL): EST  (last updated September 1, 2020)
Translation of package information leaflet into Russian: RUS  (last updated September 1, 2020)
Translation of package information leaflet into English: ENG  (last updated September 1, 2020)
Labelling:  (last updated September 1, 2020)
Last imported to Estonia: April 11, 2024
Marketing authorization holder: Mepha Investigacao Desenvolvimento E Fabricacao Farmaceutica Lda. 
Marketing authorization number: 1009420 
Marketing authorization issued on: September 1, 2020 
Marketing authorization expires on: September 1, 2025 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Entry/Changing date: September 14, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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