Medicinal product name | Salofalk 500 mg prolonged release granules |
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Pharmaceutical form | Prolonged-release granules |
Strength | 500 mg |
Information from the MAH on shortages |
Not available predicted availability date: not notified |
Legal status | Prescription (Pr.) |
Package leaflet | 13-04-2023 |
Summary of product characteristics | 13-04-2023 |
ATC code | A07EC02 – Antidiarrheals, intestinal antiinflammatory/antiinfective agents |
Information for Marketing authorisation holders | View |
Additional information regarding the use for persons aged 75+
If used as "ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS" | ||
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Substance | Class | Comment |
Mesalazinum | C | Suitable for older adults, with specific precautions. Consider renal impairment. Do not use in severe renal impairment. |
Medicinal products (3)
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 |
N50 (500 mg) |
Polyester/Al/PE sachet | 13-0203-01 |
Labelling text Apr 13, 2023 Labelling text Apr 13, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N100 (500 mg) |
Polyester/Al/PE sachet | 13-0203-02 |
Labelling text Apr 13, 2023 Labelling text Apr 13, 2023 |
|
Not available (according to the information provided by wholesalers) | currently no information on availability from any wholesaler |
N300 (500 mg) |
Polyester/Al/PE sachet | 13-0203-03 |
Labelling text Apr 13, 2023 Labelling text Apr 13, 2023 |
Registration information
Marketing authorisation No. | 13-0203 |
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Date of authorisation | Sep 25, 2013 |
Marketing authorisation holder, country | Dr. Falk Pharma GmbH, Germany |