Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: OLFEN
Active substances:
Estonian, English, Latin
ATC code: M02AA15
Dosage form: gel
Strength: 23,2mg 1g
Legal status for supply*: Not subject to medicinal prescription
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)
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
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 
Assessment report:   
Description Additional condition
Hambaarstil on õigus välja kirjutada
Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1792357  OLFEN  gel  23,2mg 1g 30g 1TK  OTC           
1792368  OLFEN  gel  23,2mg 1g 50g 1TK  OTC      14.05.2024     
1792379  OLFEN  gel  23,2mg 1g 60g 1TK  OTC           
1792380  OLFEN  gel  23,2mg 1g 100g 1TK  OTC      14.05.2024     
1792391  OLFEN  gel  23,2mg 1g 150g 1TK  OTC           
1792403  OLFEN  gel  23,2mg 1g 180g 1TK  OTC           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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