The Risk Management Plans (RMPs) are comprehensive documents submitted as part of the application dossiers for market approval of medicinal products. The RMP summaries contain information on the medicinal products′ safety profiles and explain the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimise them.
The RMP summaries published are concise documents and do not claim to be exhaustive. As the RMPs are international documents, their summaries might differ from the content in the product information («Arzneimittelinformation») approved and published in Switzerland, e.g. by mentioning risks occurring in populations or indications not included in the Swiss authorisations. Please note that the reference documents, which are valid and relevant for the effective and safe use of medicinal products in Switzerland, are the «Arzneimittelinformationen» (see www.swissmedicinfo.ch) approved and authorised by Swissmedic.
The Marketing Authorisation Holders are responsible for the accuracy and correctness of the content of the here published RMP summaries.
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Documents
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Sorted by active substance
A - C
alogliptin (Vipidia®) RMP Summary (PDF, 123 kB, 07.02.2023)No longer authorised
autologus anti CD 19 transduced CD3 cells (Tecartus®) RMP Summary (PDF, 121 kB, 30.09.2023)Version 3.0
Complexus toxini botulinici A et haemagglutinini (Dysport®) RMP Summary (PDF, 152 kB, 24.01.2023)Version 7.6
Covid-19 Vaccine (Nuvaxovid®) RMP Summary (PDF, 355 kB, 01.09.2022)No longer authorised
D - F
Daclizumab (Zinbryta®): RMP summary (PDF, 123 kB, 26.11.2016)No longer authorised
Dacomitinib (Vizimpro®): RMP Summary (PDF, 1 MB, 14.05.2021)No longer authorised
Diphtheria-2/Tetanus/5AC Pertussis Vaccine (Adacel®) RMP Summary (PDF, 122 kB, 17.10.2022)Version 5.0
Elbasvir/Grazoprevir (Zepatier®): RMP summary (PDF, 367 kB, 25.02.2022)No longer authorised
Eluxadoline (Truberzi®): RMP summary (PDF, 721 kB, 26.11.2019)No longer authorised
G - K
Humaner Papillomavirus-Impfstoff 9-valent (Gardasil 9®): RMP summary (PDF, 88 kB, 08.09.2023)Version 5.1
HYNIC-D-Phe 1 Tyr 3- octeotridum_trifluoroacetum (Tektrotyd®): RMP summary (PDF, 201 kB, 30.11.2015)Version 1.0
L - N
Ledipasvir/Sofosbuvir (Harvoni®): RMP summary (PDF, 66 kB, 01.12.2020)No longer authorised
Lesinurad (Zurampic®): RMP summary (PDF, 152 kB, 15.05.2017)No longer authorised
lixisenatide (Lyxumia®) RMP Summary (PDF, 159 kB, 14.03.2022)No longer authorised
Lutetium vipivotide tetraxetan (Pluvicto/Pluvicto CA®) RMP Summary (PDF, 265 kB, 11.10.2023)Version 1.2
measles, mumps, rubella and varicella virus (Priorix Tetra®): RMP Summary (PDF, 186 kB, 01.12.2019)Version 1.0
Meningoccal groups A,C,W-135 and Y conjugate vaccine (Menveo®) RMP Summary (PDF, 184 kB, 06.03.2023)Version 1.0
MENINGOCOCCAL POLYSACCHARIDE A, C, W-135 AND Y (Menquadfi)®) RMP Summary (PDF, 226 kB, 12.09.2023)Version 1.3
Methylphenidati hydrochloridum (Ritalin/Ritalin LA)® RMP Summary (PDF, 345 kB, 08.03.2024)Version 10.2
O - R
Olaratumab (Latruvo®): RMP summary (PDF, 292 kB, 28.09.2017)No longer authorised
Quatrivalent Influenza Vaccine_cell based (Flucelvax Tetra®) RMP Summary (PDF, 820 kB, 23.01.2023)Version 2.0
Quadrivalent Recombinant Influenca Vaccine (Supemtek®) RMP Summary (PDF, 163 kB, 22.03.2021)No longer authorised
Pneumococcal Polysaccharide Conjugate Vaccine (Prevenar13)® RMP Summary (PDF, 111 kB, 12.03.2024)Version 1.0
Pneumococcal Polysaccharide Conjugate Vaccine (Prevenar 20)® RMP Summary (PDF, 119 kB, 27.02.2024)Version 1.0
Pneumoccocal polysaccharide conjugate vaccine (Vaxneuvance®) RMP Summary (PDF, 221 kB, 28.05.2024)Version 3.0
Reassortant influenza virus strains (Fluenz-Tetra®) RMP Summary (PDF, 167 kB, 28.08.2023)No longer authorised
S - U
Tedizolidphosphat (Sivextro®): RMP summary (PDF, 141 kB, 02.10.2018)No longer authorised
Tepotinibum/Tepotinibi Hydrochloridum Monohydricum (Tepmetko®) RMP Summary (PDF, 192 kB, 20.11.2022)Version 5.0
Trifluridine / tipiracil hydrochloride (Lonsurf®): RMP summary (PDF, 128 kB, 07.03.2024)Version 11.0
V - Z
Sorted...
Sorted by product name
A - C
Diphtheria-2/Tetanus/5AC Pertussis Vaccine (Adacel®) RMP Summary (PDF, 122 kB, 17.10.2022)Version 5.0
D - F
Complexus toxini botulinici A et haemagglutinini (Dysport®) RMP Summary (PDF, 152 kB, 24.01.2023)Version 7.6
Quatrivalent Influenza Vaccine_cell based (Flucelvax Tetra®) RMP Summary (PDF, 820 kB, 23.01.2023)Version 2.0
G - K
Humaner Papillomavirus-Impfstoff 9-valent (Gardasil 9®): RMP summary (PDF, 88 kB, 08.09.2023)Version 5.1
Ledipasvir/Sofosbuvir (Harvoni®): RMP summary (PDF, 66 kB, 01.12.2020)No longer authorised
L - N
Olaratumab (Latruvo®): RMP summary (PDF, 292 kB, 28.09.2017)No longer authorised
Trifluridine / tipiracil hydrochloride (Lonsurf®): RMP summary (PDF, 128 kB, 07.03.2024)Version 11.0
lixisenatide (Lyxumia®) RMP Summary (PDF, 159 kB, 14.03.2022)No longer authorised
MENINGOCOCCAL POLYSACCHARIDE A, C, W-135 AND Y (Menquadfi)®) RMP Summary (PDF, 226 kB, 12.09.2023)Version 1.3
Meningoccal groups A,C,W-135 and Y conjugate vaccine (Menveo®) RMP Summary (PDF, 184 kB, 06.03.2023)Version 1.0
Covid-19 Vaccine (Nuvaxovid®) RMP Summary (PDF, 355 kB, 01.09.2022)No longer authorised
O - R
Lutetium vipivotide tetraxetan (Pluvicto/Pluvicto CA®) RMP Summary (PDF, 265 kB, 11.10.2023)Version 1.2
Pneumococcal Polysaccharide Conjugate Vaccine (Prevenar13)® RMP Summary (PDF, 111 kB, 12.03.2024)Version 1.0
Pneumococcal Polysaccharide Conjugate Vaccine (Prevenar 20)® RMP Summary (PDF, 119 kB, 27.02.2024)Version 1.0
measles, mumps, rubella and varicella virus (Priorix Tetra®): RMP Summary (PDF, 186 kB, 01.12.2019)Version 1.0
S - U
Tedizolidphosphat (Sivextro®): RMP summary (PDF, 141 kB, 02.10.2018)No longer authorised
Quadrivalent Recombinant Influenca Vaccine (Supemtek®) RMP Summary (PDF, 163 kB, 22.03.2021)No longer authorised
autologus anti CD 19 transduced CD3 cells (Tecartus®) RMP Summary (PDF, 121 kB, 30.09.2023)Version 3.0
HYNIC-D-Phe 1 Tyr 3- octeotridum_trifluoroacetum (Tektrotyd®): RMP summary (PDF, 201 kB, 30.11.2015)Version 1.0
Tepotinibum/Tepotinibi Hydrochloridum Monohydricum (Tepmetko®) RMP Summary (PDF, 192 kB, 20.11.2022)Version 5.0
Eluxadoline (Truberzi®): RMP summary (PDF, 721 kB, 26.11.2019)No longer authorised
V - Z
Rolapitant hydrochloride monohydrate (Varuby®): RMP summary (PDF, 149 kB, 23.11.2018)No longer authorised
Influenza virus_inactivated_split (VaxigripTetra®): RMP summary (PDF, 210 kB, 15.03.2017)Version 5.0
Pneumoccocal polysaccharide conjugate vaccine (Vaxneuvance®) RMP Summary (PDF, 221 kB, 28.05.2024)Version 3.0
alogliptin (Vipidia®) RMP Summary (PDF, 123 kB, 07.02.2023)No longer authorised
Dacomitinib (Vizimpro®): RMP Summary (PDF, 1 MB, 14.05.2021)No longer authorised
Elbasvir/Grazoprevir (Zepatier®): RMP summary (PDF, 367 kB, 25.02.2022)No longer authorised
Daclizumab (Zinbryta®): RMP summary (PDF, 123 kB, 26.11.2016)No longer authorised
Lesinurad (Zurampic®): RMP summary (PDF, 152 kB, 15.05.2017)No longer authorised
Last modification 16.12.2024