Medicines authorised with a summary of the risk management plan (sRMP)

In connection with the approval of a risk management plan for a medicinal product for human use, a summary of the risk management plan for the medicinal product is prepared and made publicly available in accordance with the pharmacovigilance legislation which came into force in July 2012.

The summary is prepared by the marketing authorisation holder and approved by the Danish Medicines Agency. On the EMA's website, you can find the summaries of risk management plans for medicinal products with an authorisation granted under the Centralised Procedure.

You can find the summaries of risk management plans by searching for the product name or the active substance.

You can also find a summary of risk management plan by clicking the first letter of the relevant product name below.

Since medicinal products sometimes change names there can be divergent names in the summary of the risk management plan and on this website.

The name on the website will always be the most recently approved name for the product.

The name in the summary of the risk management plan can be a previously approved name of the product or the name(s) of the active substance(s).

Product Name Pharmaceutical Form Strength Active Substance Approval Date
Pemetrexed "Hexal" koncentrat til infusionsvæske, opløsning; 25 mg/ml Pemetrexeddinatriumhemipentahydrat 10/06/2020
Pemetrexed "Norameda" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Pemetrexeddikaliumheptahydrat 28/09/2017
Pemetrexed "Orion" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Pemetrexeddinatrium 08/12/2016
Pemetrexed "Orion" pulver til koncentrat til infusionsvæske, opløsning; 500 mg Pemetrexeddinatrium 08/12/2016
Pemetrexed "Reig Jofre" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Pemetrexeddinatrium 24/11/2016
Pemetrexed "Reig Jofre" pulver til koncentrat til infusionsvæske, opløsning; 500 mg Pemetrexeddinatrium 24/11/2016
Pemetrexed "STADA" koncentrat til infusionsvæske, opløsning; 25 mg/ml Pemetrexeddinatrium 20/12/2017
Pemetrexed "Synthon Hispania" koncentrat til infusionsvæske, opløsning; 25 mg/ml Pemetrexed 08/11/2017
Pemetrexed "Teva B.V." koncentrat til infusionsvæske, opløsning; 25 mg/ml Pemetrexed 24/04/2017
Pemetrexed "Teva" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Pemetrexed 03/12/2015
Pemetrexed "Teva" pulver til koncentrat til infusionsvæske, opløsning; 500 mg Pemetrexed 03/12/2015
Penomax filmovertrukne tabletter; 400 mg Pivmecillinamhydrochlorid 18/06/2015
Pentasa Sachet depotgranulat, enkeltdosisbeholder; 4 g MESALAZIN 09/06/2015
Penthrox væske til inhalationsdamp; 99,9 %, 3 ml METHOXYFLURAN 11/12/2017
Pentiro filmovertrukne tabletter; 100+25+200 mg CARBIDOPAMONOHYDRAT, ENTACAPON, LEVODOPA 06/08/2014
Pentiro filmovertrukne tabletter; 150+37,5+200 mg CARBIDOPAMONOHYDRAT, ENTACAPON, LEVODOPA 06/08/2014
Pentiro filmovertrukne tabletter; 175+43,75+200 mg CARBIDOPAMONOHYDRAT, ENTACAPON, LEVODOPA 06/08/2014
Pentiro filmovertrukne tabletter; 200+50+200 mg CARBIDOPAMONOHYDRAT, ENTACAPON, LEVODOPA 06/08/2014
Pentiro filmovertrukne tabletter; 50+12,5+200 mg CARBIDOPAMONOHYDRAT, ENTACAPON, LEVODOPA 06/08/2014
Pharmiso kapsler, bløde; 10 mg Isotretinoin 16/01/2019
Pharmiso kapsler, bløde; 20 mg Isotretinoin 16/01/2019
Phenoxymethylpenicillinkalium "EQL Pharma" filmovertrukne tabletter; 800 mg Phenoxymethylpenicillinkalium 12/02/2015
Phosphoral oral opløsning; Dinatriumphosphat, PHOSPHORSYRE, KONCENTRERET 24/03/2017
Phybag injektionsvæske, opløsning; 9 mg/ml NATRIUMCHLORID 17/12/2015
Physioneal 35 Glucose 1,36% w/v/13,6 mg/ml peritonealdialysevæske; 13,6 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 35 Glucose 1,36% w/v/13,6 mg/ml Clear-F peritonealdialysevæske; 13,6 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 35 Glucose 2,27% w/v/22,7 mg/ml peritonealdialysevæske; 22,7 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 35 Glucose 2,27% w/v/22,7 mg/ml Clear-F peritonealdialysevæske; 22,7 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 35 Glucose 3,86% w/v/38,6 mg/ml peritonealdialysevæske; 38,6 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 35 Glucose 3,86% w/v/38,6 mg/ml Clear-F peritonealdialysevæske; 38,6 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 40 Glucose 1,36% w/v/13,6 mg/ml peritonealdialysevæske; 13,6 mg/ml GLUCOSEMONOHYDRAT 11/07/2019
Physioneal 40 Glucose 1,36% w/v/13,6 mg/ml Clear-F peritonealdialysevæske; 13,6 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, Natrium(S)-lactat opløsning, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 40 Glucose 2,27% w/v/22,7 mg/ml peritonealdialysevæske; 22,7 mg/ml GLUCOSEMONOHYDRAT 11/07/2019
Physioneal 40 Glucose 2,27% w/v/22,7 mg/ml Clear-F peritonealdialysevæske; 22,7 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019
Physioneal 40 Glucose 3,86% w/v/38,6 mg/ml peritonealdialysevæske; 38,6 mg/ml GLUCOSEMONOHYDRAT 11/07/2019
Physioneal 40 Glucose 3,86% w/v/38,6 mg/ml Clear-F peritonealdialysevæske; 38,6 mg/ml CALCIUMCHLORIDDIHYDRAT, GLUCOSEMONOHYDRAT, MAGNESIUMCHLORIDHEXAHYDRAT, NATRIUM(S)-LACTAT, NATRIUMCHLORID, NATRIUMHYDROGENCARBONAT 11/07/2019

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