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Marketing authorisation has been revoked pursuant to COMMISSION IMPLEMENTING DECISION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. |