Pembrolizumabum
| Medicinal product name | Keytruda |
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|---|---|---|---|---|---|---|---|
| Pharmaceutical form | Concentrate for solution for infusion | ||||||
| Strength | 25 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.) NHS Reimbursed medicines |
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| Summary of product characteristics, package leaflet and labeling text |
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
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| Risk minimisation measures |  Izglītojošie materiāli pacientam Vēstule veselības aprūpes speciālistam | ||||||
| Conclusion on the therapeutic and cost effectiveness of medicines | Feb 10, 2021 C43 Jan 20, 2021 C34 Jun 4, 2021 C00-C14, C30-C32 Aug 17, 2021 C34 Sep 9, 2022 C50 Dec 20, 2022 C50 Apr 27, 2023 C64 Apr 14, 2023 C18 C19 C20 Jun 1, 2023 C53 Aug 11, 2023 C15 C16.0 Nov 7, 2023 C54.1 C16 C17 C22.1 C24 Mar 21, 2024 C64 Apr 11, 2024 C64 | ||||||
| ATC code | L01FF02 – Antineoplastic agents |
Medicinal products (1)
| Availability of medicinal product | Wholesalers | Package size, content | Primary packaging | Maximum admissible pharmacy price (€ incl. VAT) | Product No. | Labelling |
|---|---|---|---|---|---|---|
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Is available (according to the information provided by wholesalers) (60 containers) |
Tamro |
N1 (100 mg/4 ml) |
Glass vial |
€ 4836.94 * |
EU/1/15/1024/002 |
Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
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* Indication about medicine on the List of state reimbursed medicines is just informative. Source of the information is the National Health Service. For details please visit the NHS website.
Registration information
| Marketing authorisation No. | EU/1/15/1024/002 |
|---|---|
| Date of authorisation | Jul 17, 2015 |
| Marketing authorisation holder, country | Merck Sharp & Dohme B.V., Netherlands |
