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
Ambrisentan "Accord" filmovertrukne tabletter; 10 mg Ambrisentan 03/09/2019
Ambrisentan "Accord" filmovertrukne tabletter; 5 mg Ambrisentan 03/09/2019
Ambrisentan "Sandoz" filmovertrukne tabletter; 10 mg Ambrisentan 10/09/2019
Ambrisentan "Sandoz" filmovertrukne tabletter; 5 mg Ambrisentan 10/09/2019
Ambrisentan "Teva" filmovertrukne tabletter; 10 mg Ambrisentan 15/01/2020
Ambrisentan "Teva" filmovertrukne tabletter; 5 mg Ambrisentan 15/01/2020
Amekrin koncentrat og solvens til koncentrat til infusionsvæske, opløsning; 75 mg/1,5 ml AMSACRIN 14/11/2013
Amikacin "Macure" injektionsvæske, opløsning; 250 mg/ml Amikacinsulfat 10/06/2020
Amiodaron "Hameln" koncentrat til injektions-/infusionsvæske, opløsning; 50 mg/ml AMIODARONHYDROCHLORID 13/02/2018
Amisulprid "Medochemie Romania" tabletter; 100 mg AMISULPRID 17/04/2019
Amisulprid "Medochemie Romania" tabletter; 200 mg AMISULPRID 17/04/2019
Amisulprid "Medochemie Romania" tabletter; 400 mg AMISULPRID 17/04/2019
Amisulprid "Medochemie Romania" tabletter; 50 mg AMISULPRID 17/04/2019
Amitriptylin "Abcur" filmovertrukne tabletter; 10 mg Amitriptylinhydrochlorid 08/11/2018
Amitriptylin "Abcur" filmovertrukne tabletter; 25 mg Amitriptylinhydrochlorid 08/11/2018
Amitriptylin "Abcur" filmovertrukne tabletter; 50 mg AMITRIPTYLIN 08/11/2018
Amlodipin "Accord" tabletter; 10 mg AMLODIPINBESILAT 15/03/2017
Amlodipin "Accord" tabletter; 5 mg AMLODIPINBESILAT 15/03/2017
Amlodipin "Aurobindo" tabletter; 10 mg AMLODIPINBESILAT 26/10/2016
Amlodipin "Aurobindo" tabletter; 5 mg AMLODIPINBESILAT 26/10/2016
Amlodipin "Essential Pharmaceuticals" oral suspension; 1 mg/ml AMLODIPINBESILAT
Amlodipin "Medical Valley" tabletter; 10 mg AMLODIPINBESILAT 27/02/2019
Amlodipin "Medical Valley" tabletter; 5 mg AMLODIPINBESILAT 27/02/2019
Amlodipin "Sandoz" tabletter; 10 mg AMLODIPINBESILAT 22/01/2014
Amlodipin "Sandoz" tabletter; 5 mg AMLODIPINBESILAT 22/01/2014
Amlodipin "Sandoz" tabletter; 7,5 mg AMLODIPINBESILAT 22/01/2014
Amlodipin/valsartan "Stada" filmovertrukne tabletter; 10/160 mg AMLODIPINBESILAT, VALSARTAN 11/04/2016
Amlodipin/valsartan "Stada" filmovertrukne tabletter; 5/160 mg AMLODIPINBESILAT, VALSARTAN 11/04/2016
Amlodipin/valsartan "Stada" filmovertrukne tabletter; 5/80 mg AMLODIPINBESILAT, VALSARTAN 11/04/2016
Amlodipine/Valsartan/Hydrochlorothiazide "Krka" filmovertrukne tabletter; 10+160+12,5 mg AMLODIPINBESILAT, HYDROCHLORTHIAZID, VALSARTAN 21/01/2019
Amlodipine/Valsartan/Hydrochlorothiazide "Krka" filmovertrukne tabletter; 10+160+25 mg AMLODIPINBESILAT, HYDROCHLORTHIAZID, VALSARTAN 21/01/2019
Amlodipine/Valsartan/Hydrochlorothiazide "Krka" filmovertrukne tabletter; 10+320+25 mg AMLODIPINBESILAT, HYDROCHLORTHIAZID, VALSARTAN 21/01/2019
Amlodipine/Valsartan/Hydrochlorothiazide "Krka" filmovertrukne tabletter; 5+160+12,5 mg AMLODIPINBESILAT, HYDROCHLORTHIAZID, VALSARTAN 21/01/2019
Amlodipine/Valsartan/Hydrochlorothiazide "Krka" filmovertrukne tabletter; 5+160+25 mg AMLODIPINBESILAT, HYDROCHLORTHIAZID, VALSARTAN 21/01/2019
Amlodistad tabletter; 10 mg AMLODIPINBESILAT 12/11/2014
Amlodistad tabletter; 5 mg AMLODIPINBESILAT 12/11/2014
Amlodorion tabletter; 10 mg AMLODIPINBESILAT 01/11/2017
Amlodorion tabletter; 5 mg AMLODIPINBESILAT 01/11/2017
Amorina tabletter; 0,250+0,035 mg Ethinylestradiol, NORGESTIMAT 15/07/2020
Ampres injektionsvæske, opløsning; 10 mg/ml CHLORPROCAINHYDROCHLORID 16/03/2020
Ampres injektionsvæske, opløsning; 20 mg/ml CHLORPROCAINHYDROCHLORID 16/03/2020
Anagrelid "AOP" kapsler, hårde; 0,5 mg ANAGRELIDHYDROCHLORID 08/03/2018
Anagrelid "Bluefish" kapsler, hårde; 0,5 mg ANAGRELIDHYDROCHLORID 03/05/2018
Anagrelid "Teva" kapsler, hårde; 0,5 mg ANAGRELIDHYDROCHLORID 10/11/2017
Anagrelid "Zentiva" kapsler, hårde; 0,5 mg ANAGRELIDHYDROCHLORID 05/10/2017
Anagrelide "Glenmark" kapsler, hårde; 0,5 mg Anagrelidhydrochloridmonohydrat 06/12/2017
Anagrelide "Sandoz" kapsler, hårde; 0,5 mg Anagrelidhydrochloridmonohydrat 06/12/2017
Anagrelide "Stada" kapsler, hårde; 0,5 mg ANAGRELIDHYDROCHLORID 05/10/2017
Anatera injektionsvæske, opløsning; 100 mg/ml Fluoresceinnatrium 21/01/2019
Androgel gel; 16,2 mg/g TESTOSTERONENANTAT 11/11/2015
Angusta tabletter; 25 mikrogram MISOPROSTOL 15/02/2017
Anidulafungin "Accord" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Anidulafungin 30/10/2018
Anidulafungin "Fresenius Kabi" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Anidulafungin 04/09/2019
Anidulafungin "Reig Jofre" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Anidulafungin 11/03/2020
Anidulafungin "Sandoz" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Anidulafungin 14/11/2018
Anidulafungin "Teva" pulver til koncentrat til infusionsvæske, opløsning; 100 mg Anidulafungin 17/01/2018
Antitrombin III "Baxalta" pulver og solvens til injektions- /infusionsvæske, opløsning; Antitrombin III 31/10/2017
Antoreq depottabletter; 150 mg QUETIAPIN FUMARAT 11/11/2014
Antoreq depottabletter; 200 mg QUETIAPIN FUMARAT 11/11/2014
Antoreq depottabletter; 300 mg QUETIAPIN FUMARAT 11/11/2014
Antoreq depottabletter; 400 mg QUETIAPIN FUMARAT 11/11/2014
Antoreq depottabletter; 50 mg QUETIAPIN FUMARAT 11/11/2014
Aphiahsone næsespray, suspension; 50 mikrogram/dosis Mometasonfuroat monohydrat 05/11/2018
APO-go POD infusionsvæske, opløsning i cylinderampul; 5 mg/ml Apomorphinhydrochlorid hemihydrat 07/06/2020
Apotel infusionsvæske, opløsning; 10 mg/ml PARACETAMOL 16/04/2015
Aprepitant "Sandoz" kapsler, hårde; 125 mg APREPITANT 04/12/2017
Aprepitant "Sandoz" kapsler, hårde; 125+80 mg APREPITANT 04/12/2017
Aprepitant "Sandoz" kapsler, hårde; 80 mg APREPITANT 04/12/2017
Aprepitant "Stada" kapsler, hårde; 80 mg APREPITANT 14/12/2018
Aprokam pulver til injektionsvæske, opløsning; 50 mg CEFUROXIMNATRIUM 02/03/2016

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