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 |
| 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 | Medicinal product subject to medical prescription |
| Type of prescription | neponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | R05DA08 |
| 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Marketing authorisation has been revoked pursuant to COMMISSION IMPLEMENTING DECISION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”
Packaging
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. |
