Medicinal product name | Fluorouracil Accord 50 mg/ml solution for injection or infusion |
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Pharmaceutical form | Solution for injection/infusion | |||||||||
Strength | 50 mg/ml | |||||||||
Information from the MAH on shortages | No information on expected shortages | |||||||||
Availability of medicinal product |
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Legal status | Prescription (Pr.) | |||||||||
Package leaflet | 16-01-2024 | |||||||||
Summary of product characteristics | 16-01-2024 | |||||||||
Risk minimisation measures | Vēstule veselības aprūpes speciālistam | |||||||||
ATC code | L01BC02 – Antineoplastic agents | |||||||||
Information for Marketing authorisation holders | View |
Medicinal products (5)
Availability of medicinal product | Wholesalers | Package size, content | Primary packaging | Maximum admissible pharmacy price (€ incl. VAT) | Product No. | Labelling |
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Not available (according to the information provided by wholesalers) predicted availability date: not notified |
currently no information on availability from any wholesaler |
N1 (250 mg/5 ml) |
Glass vial | 09-0458-01 |
Labelling text May 30, 2019 |
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Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N1 (500 mg/10 ml) |
Glass vial | 09-0458-02 |
Labelling text May 30, 2019 |
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Is available (according to the information provided by wholesalers) (494 containers) |
Recipe Plus |
N1 (1000 mg/20 ml) |
Glass vial | € 7.29 | 09-0458-03 |
Labelling text May 30, 2019 |
Is available (according to the information provided by wholesalers) (245 containers) |
Recipe Plus |
N1 (5000 mg/100 ml) |
Glass vial | € 25.42 | 09-0458-04 |
Labelling text May 30, 2019 |
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N1 (2500 mg/50 ml) |
Glass vial | 09-0458-05 |
Labelling text May 30, 2019 |
Registration information
Marketing authorisation No. | 09-0458 |
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Date of authorisation | Nov 27, 2009 |
Marketing authorisation holder, country | Accord Healthcare B.V., Netherlands |