Medicinal Products

Pholcodin Alkaloid 10 mg tvrde kapsule

Name Pholcodin Alkaloid 10 mg tvrde kapsule
Marketing Authorisation Number HR-H-813937465
Active Substance folkodin hidrat
Composition jedna kapsula sadrži 10 mg folkodin hidrata
Pharmaceutical Form kapsula, tvrda
Packaging [MA Number for Packaging] 20 kapsula u blisteru, u kutiji  [HR-H-813937465-01]
Manufacturer Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija
Marketing Authorisation Holder Alkaloid d.o.o., Slavonska avenija 6 A, Zagreb, Hrvatska
Marketing Authorisation Date 13.02.2018
MA Period of Validity unlimited
MA Revocation Date 07.04.2023*
Classification Number UP/I-530-09/16-02/502
Registration Number 381-12-01/38-18-07
Prescription na recept
Type of prescription neponovljivi recept
Distribution u ljekarni
Advertising to general public zabranjeno
ATC Code R05DA08
Medicinal product marketed in the Croatia Trajni prekid opskrbe
SmPC download
PL download

*Note

Marketing authorisation has been revoked pursuant to COMMISSION IMPLEMENTING DECISION
of 6.3.2023. concerning, in the framework of Article 107i of Directive 2001/83/EC of the European
Parliament and of the Council, the marketing authorisations of medicinal products for
human use which contain the active substance “pholcodine / pholcodine-containing
medicinal products”

Direct Healthcare Professional Communication

Name Date Download
Pismo zdravstvenim radnicima o ukidanju odobrenja za lijekove koji sadrže folkodin i povlačenju s tržišta EU-a 03.04.2023 Alkaloid d.o.o.
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