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96 results

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Medicine Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter

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Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

valsartan, candesartan, irbesartan, losartan and olmesartan, associated names: Karvezide, Karvea, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Irbesartan Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Ifirmasta (previously Irbesartan Krka), Ifirmacombi, Aprovel, Neparvis, Exforge, Exforge HCT, Entresto, Dafiro HCT, Dafiro, Copalia HCT, Copalia, Amlodipine / Valsartan Mylan , CoAprovel, Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 12/11/2020, Last updated: 13/11/2020
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Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products

capecitabine, fluorouracil, tegafur, flucytosine, associated names: Xeloda, Teysuno, Capecitabine Accord, Capecitabine Medac, Capecitabine Teva, Ecansya (previously Capecitabine Krka), Article 31 referrals
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 07/07/2020, Last updated: 23/07/2020
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Referral: Lartruvo

olaratumab, associated names: Lartruvo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 31/01/2019, EC decision date: 19/07/2019, Last updated: 22/08/2019
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Referral: Factor VIII

associated names: Iblias, Elocta, Kovaltry, Nuwiq, Obizur, NovoEight, Voncento, ReFacto AF, Kogenate Bayer, Helixate NexGen, Advate, Article 31 referrals
Status: European Commission final decision, opinion/position date: 14/09/2017, EC decision date: 10/10/2017, Last updated: 05/12/2017
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Referral: Renin-angiotensin-system (RAS)-acting agents

captopril, imidapril, zofenopril, candesartan, delapril, telmisartan, aliskiren, moexipril, enalapril, valsartan, fosinopril, irbesartan, perindopril, quinapril, ramipril, eprosartan, olmesartan, trandolapril, losartan, azilsartan, lisinopril, spirapril, benazepril, cilazapril, associated names: Tolucombi, Telmisartan Teva, Telmisartan Teva Pharma, Tolura, Onduarp, Twynsta, Actelsar HCT, Kinzalkomb, MicardisPlus, PritorPlus, Copalia HCT, Dafiro HCT, Exforge HCT, Rasilamlo, Rasilez, Rasilez HCT, Rasitrio, Edarbi, Ipreziv, Aprovel, Ifirmasta (previously Irbesartan Krka), Irbesartan Teva, Irbesartan Zentiva (previously Irbesartan Winthrop), Karvea, Sabervel, CoAprovel, Ifirmacombi, Irbesartan/Hydrochlorothiazide Teva, Irbesartan Hydrochlorothiazide Zentiva (previously Irbesartan Hydrochlorothiazide Winthrop), Karvezide, Kinzalmono (previously Telmisartan Boehringer Ingelheim Pharma KG), Micardis, Pritor, Telmisartan Actavis, Article 31 referrals
Status: European Commission final decision, opinion/position date: 22/05/2014, EC decision date: 04/09/2014, Last updated: 08/10/2014
List item

Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity

Active substance: Fluorouracil, capecitabine, tegafur, DHPC type: Referral - Article 31, Last updated: 04/06/2020
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa

Active substance: andexanet alfa, DHPC type: Safety signal, Last updated: 17/06/2020
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Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter

Active substance: Letermovir, Last updated: 11/09/2020
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Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion

Active substance: cabazitaxel, DHPC type: Medication error, Last updated: 28/10/2020
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Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

Active substance: andexanet alfa, DHPC type: Adverse event, Last updated: 04/11/2020
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Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)

Active substance: Pirfenidone, DHPC type: Type II variation, Last updated: 29/10/2020
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Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet

Active substance: Metreleptin, DHPC type: Quality defect, Last updated: 18/06/2020
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Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)

Active substance: polatuzumab vedotin, DHPC type: Quality defect, Last updated: 04/05/2020
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Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-001659-PIP01-15-M04, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Solution for injection
Decision date: 18/03/2020, Last updated: 04/08/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-000914-PIP01-10-M05, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 18/03/2020, Last updated: 03/08/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Neurology
PIP number: EMEA-000876-PIP03-14-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Concentrate for solution for infusion
Decision date: 21/03/2020, Last updated: 03/08/2020, Compliance check: X
List item

Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001429-PIP01-13-M03, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder for concentrate for solution for infusion
Decision date: 10/02/2020, Last updated: 12/06/2020, Compliance check: X
List item

Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: EMEA-001107-PIP01-10-M04, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Powder and solvent for solution for infusion, Powder and solvent for solution for injection
Decision date: 29/01/2020, Last updated: 11/06/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Other
PIP number: EMEA-002012-PIP01-16-M02, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Oral solution
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Endocrinology, -gynacology-fertility-metabolism
PIP number: EMEA-001915-PIP01-15-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Solution for injection
Decision date: 04/12/2019, Last updated: 02/04/2020, Compliance check: X
List item

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Immunology-Rheumatology-Transplantation
PIP number: EMEA-001397-PIP04-17-M01, Route(s) of administration: Oral use, Gastric use, Pharmaceutical form(s): Capsule, hard, Film-coated tablet, Oral suspension
Decision date: 06/12/2019, Last updated: 01/04/2020, Compliance check: X
List item

Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Gastroentology-Hepatology
PIP number: EMEA-000482-PIP01-08-M05, Route(s) of administration: Subcutaneous use, Pharmaceutical form(s): Powder and solvent for solution for injection
Decision date: 06/12/2019, Last updated: 31/03/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Prevymis, Letermovir

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Infectious diseases
PIP number: EMEA-001631-PIP01-14-M04, Route(s) of administration: Oral use, Intravenous use, Pharmaceutical form(s): Film-coated tablet, Granules, Concentrate for solution for infusion
Decision date: 04/11/2019, Last updated: 30/03/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001654-PIP02-17-M01, Route(s) of administration: Intravenous use, Pharmaceutical form(s): Dispersion for infusion
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X
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Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib

Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Oncology
PIP number: EMEA-001143-PIP01-11-M02, Route(s) of administration: Oral use, Pharmaceutical form(s): Age-appropriate oral solid dosage form, Tablet, Capsule, hard
Decision date: 11/09/2019, Last updated: 26/03/2020, Compliance check: X

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96 results

Referral: Angiotensin-II-receptor antagonists (sartans) containing a tetrazole group

Referral: Fluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products

Referral: Lartruvo

Referral: Factor VIII

Referral: Renin-angiotensin-system (RAS)-acting agents

Direct healthcare professional communication (DHPC): 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity

Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Commercial anti-FXa activity assays are unsuitable for measuring anti-FXa activity following administration of andexanet alfa

Direct healthcare professional communication (DHPC): Prevymis (letermovir) concentrate for solution for infusion - Essential to administer through sterile 0.2 micron or 0.22 micron polyethersulfone (PES) in-line filter

Direct healthcare professional communication (DHPC): Cabazitaxel Accord 20 mg/mL concentrate for solution for infusion: Risk of medication errors and mix-up with Jevtana (60 mg/1.5 mL) concentrate and solvent for solution for infusion

Direct healthcare professional communication (DHPC): Ondexxya (andexanet alfa): Avoid use of andexanet prior to heparinization

Direct healthcare professional communication (DHPC): Esbriet (pirfenidone): Important safety update and new recommendations to prevent Drug-Induced Liver Injury (DILI)

Direct healthcare professional communication (DHPC): Myalepta (metreleptin): inconsistencies in the package leaflet

Direct healthcare professional communication (DHPC): Polivy (polatuzumab vedotin)

Opinion/decision on a Paediatric investigation plan (PIP): Crysvita, Burosumab

Opinion/decision on a Paediatric investigation plan (PIP): Alprolix, eftrenonacog alfa

Opinion/decision on a Paediatric investigation plan (PIP): Soliris, Eculizumab

Opinion/decision on a Paediatric investigation plan (PIP): Besponsa, inotuzumab ozogamicin

Opinion/decision on a Paediatric investigation plan (PIP): Idelvion, albutrepenonacog alfa

Opinion/decision on a Paediatric investigation plan (PIP): Namuscla, Mexiletine hydrochloride

Opinion/decision on a Paediatric investigation plan (PIP): Waylivra, Volanesorsen

Opinion/decision on a Paediatric investigation plan (PIP): Imbruvica, Ibrutinib

Opinion/decision on a Paediatric investigation plan (PIP): Revestive, teduglutide

Opinion/decision on a Paediatric investigation plan (PIP): Prevymis, Letermovir

Opinion/decision on a Paediatric investigation plan (PIP): Kymriah, tisagenlecleucel

Opinion/decision on a Paediatric investigation plan (PIP): Cometriq, cabozantinib