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SwedishArticle Contents
A.MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Name and address of the manufacturer responsible for batch release
Orion Corporation
- Stalevo - levodopa / carbidopa / entacapone
- Comtan - entacapone
- Entacapone teva - entacapone
- Entacapone orion - entacapone
Prescription drugs listed. Substance: "Entacapone"
Orionintie 1
Finland
- Stalevo - Orion Corporation
- Fareston - Orion Corporation
- Dexdor - Orion Corporation
- Entacapone orion - Orion Corporation
Prescription drugs listed. Manufacturer: "Orion Corporation"
B.CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Medicinal product subject to medical prescription.
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
- Entacapone orion - N04BX02
- Entacapone teva - N04BX02
- Comtan - N04BX02
Prescription drugs listed. ATC Code: "N04BX02"
Periodic Safety Update Reports
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web portal.
- Armisarte (pemetrexed actavis)
- Modigraf
- Pemetrexed lilly
- Ibandronic acid accord
- Sylvant
- Fluenz tetra
Prescription drugs listed:
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Risk Management Plan (RMP)
Not applicable.
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