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Paediatric investigation plans Remove Paediatric investigation plans filter Referrals Remove Referrals filter Direct healthcare professional communication Remove Direct healthcare professional communication filter European public assessment reports (EPAR) (1937) Apply European public assessment reports (EPAR) filter Summaries of opinion (57) Apply Summaries of opinion filter Withdrawn applications (292) Apply Withdrawn applications filter Orphan designations (2639) Apply Orphan designations filter Maximum residue limits (801) Apply Maximum residue limits filter Opinions on maximum residue limits (12) Apply Opinions on maximum residue limits filter Periodic safety update report single assessments (2224) Apply Periodic safety update report single assessments filter Shortages (33) Apply Shortages filter Opinions on medicines for use outside EU (14) Apply Opinions on medicines for use outside EU filter

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P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) (615) Apply P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s) filter PM: decision on the application for modification of an agreed PIP (795) Apply PM: decision on the application for modification of an agreed PIP filter RP: decision refers to a refusal on a proposed Paediatric Investigation Plan (19) Apply RP: decision refers to a refusal on a proposed Paediatric Investigation Plan filter RPM: decision refers to a refusal on the application for modification of an agreed PIP (11) Apply RPM: decision refers to a refusal on the application for modification of an agreed PIP filter RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) (34) Apply RW: decision refers to a refusal on a request for waiver in all age groups for the listed condition(s) filter W: decision granting a waiver in all age groups for all conditions or indications (924) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

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3031 results

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Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage (updated)

Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022
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Referral: Daruph and Anafezyn (updated)

dasatinib (anhydrous), Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 18/07/2022, Last updated: 09/08/2022
List item

Referral: Amfepramone-containing medicinal products (updated)

amfepramone, associated names: regenon, Regenon Retard, Tenuate, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 03/08/2022
List item

Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm (updated)

Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022
List item

Referral: Rubraca (updated)

rucaparib, associated names: Rubraca, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 21/07/2022, Last updated: 22/07/2022
List item

Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome

terlipressin, Article 31 referrals
Status: Under evaluation, Last updated: 08/07/2022
List item

Referral: Nomegestrol and chlormadinone

nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: Recommendation provided by Pharmacovigilance Risk Assessment Committee, Last updated: 08/07/2022
List item

Referral: Zynteglo

betibeglogene autotemcel, associated names: Zynteglo, Article 20 procedures
Status: European Commission final decision, opinion/position date: 22/07/2021, EC decision date: 16/09/2021, Last updated: 08/07/2022
List item

Referral: Synchron

Article 31 referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 19/05/2022, Last updated: 24/06/2022
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Referral: Janus Kinase inhibitors (JAKi)

tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: Under evaluation, Last updated: 13/06/2022
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Referral: Nasolam and associated names

midazolam, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 27/01/2022, EC decision date: 01/04/2022, Last updated: 29/04/2022
List item

Referral: Etifoxine-containing medicinal products

etifoxine, associated names: Stresam, Article 31 referrals
Status: European Commission final decision, opinion/position date: 24/06/2021, EC decision date: 24/03/2022, Last updated: 21/04/2022
List item

Referral: Lidocain/Prilocain Idetec and associated names

lidocaine, prilocaine, associated names: Lidocaïne / Prilocaïne 5% Focus, Crème, Article 29(4) referrals
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 14/10/2021, Last updated: 21/04/2022
List item

Referral: Hydroxyethyl starch (HES) containing medicinal products

hydroxyethyl starch, Article 107i procedures
Status: European Commission final decision, opinion/position date: 26/10/2017, EC decision date: 17/07/2018, Last updated: 11/02/2022
List item

Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit

Active substance: varenicline, DHPC type: Medicine shortage, Last updated: 30/09/2021
List item

Referral: Intravenous iron-containing medicinal products

ferric carboxymaltose, iron dextran, sodium ferric gluconate, iron isomaltoside, iron sucrose, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/06/2013, EC decision date: 13/09/2013, Last updated: 28/07/2021
List item

Referral: Ifosfamide solutions

ifosfamide, associated names: Ifosfamide Eg, Ifo-Cell, Ifo-Cell N, Ifo-Cell N 2000, Article 31 referrals
Status: European Commission final decision, opinion/position date: 21/04/2021, EC decision date: 21/06/2021, Last updated: 19/07/2021
List item

Referral: Varilrix

live attenuated varicella virus (OKA strain), Article 30 referrals
Status: European Commission final decision, opinion/position date: 25/02/2021, EC decision date: 21/04/2021, Last updated: 09/06/2021
List item

Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)

Active substance: atezolizumab, DHPC type: Adverse event, Last updated: 25/03/2021
List item

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

valsartan, candesartan, irbesartan, losartan, 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: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 19/02/2021, Last updated: 19/03/2021
List item

Referral: Ranitidine-containing medicinal products

ranitidine, Article 31 referrals
Status: European Commission final decision, opinion/position date: 17/09/2020, EC decision date: 24/11/2020, Last updated: 17/02/2021
List item

Referral: Ulipristal acetate 5mg medicinal products

ulipristal acetate, associated names: Esmya, Ulipristal Acetate Gedeon Richter, Article 31 referrals
Status: European Commission final decision, opinion/position date: 12/11/2020, EC decision date: 11/01/2021, Last updated: 03/02/2021
List item

Referral: Picato

ingenol mebutate, associated names: Picato, Article 20 procedures
Status: European Commission final decision, opinion/position date: 30/04/2020, EC decision date: 06/07/2020, Last updated: 16/11/2020
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Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names

ibuprofen, associated names: Ibuprofen Fresenius Kabi 400 mg oplossing voor infusie, Ibuprofen Fresenius Kabi 400 mg solution pour perfusion, Ibuprofen Kabi, Ibuprofen Kabi 400 mg oldatos infúzió, Ibuprofen Kabi 400 mg soluţie perfuzabilă, Ibuprofen Kabi 400 mg, Ibuprofen Kabi 400 mg raztopina za infundiranje, Ibuprofeno Kabi 400 mg solución para perfusion, Ibuprofen Kabi 400 mg Solution for Infusion, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 23/07/2020, EC decision date: 15/10/2020, Last updated: 26/10/2020
List item

Referral: Panexcell

atazanavir, atazanavir sulfate, Amoxicillin trihydrate, iron sucrose, amoxicillin, azithromycin dihydrate, carbocisteine, trimethoprim, Article 31 referrals
Status: European Commission final decision, opinion/position date: 27/02/2020, EC decision date: 24/09/2020, Last updated: 22/10/2020

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3031 results

Direct healthcare professional communication (DHPC): Cetrorelix acetate - Cetrotide 0.25 mg Powder and solvent for injection: Temporary Shortage (updated)

Referral: Daruph and Anafezyn (updated)

Referral: Amfepramone-containing medicinal products (updated)

Direct healthcare professional communication (DHPC): Hydroxyethyl starch (HES) solutions for infusion: suspension of marketing authorisations due to continued use in contraindicated patient populations with increased risk of serious harm (updated)

Referral: Rubraca (updated)

Referral: Terlipressin-containing medicinal products indicated in the treatment of hepatorenal syndrome

Referral: Nomegestrol and chlormadinone

Referral: Zynteglo

Referral: Synchron

Referral: Janus Kinase inhibitors (JAKi)

Referral: Nasolam and associated names

Referral: Etifoxine-containing medicinal products

Referral: Lidocain/Prilocain Idetec and associated names

Referral: Hydroxyethyl starch (HES) containing medicinal products

Direct healthcare professional communication (DHPC): CHAMPIX (varenicline) - lots to be recalled due to presence of impurity N-nitroso-varenicline above the acceptable intake limit

Referral: Intravenous iron-containing medicinal products

Referral: Ifosfamide solutions

Referral: Varilrix

Direct healthcare professional communication (DHPC): Tecentriq (atezolizumab): Risk of Severe Cutaneous Adverse Reactions (SCARs)

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

Referral: Ranitidine-containing medicinal products

Referral: Ulipristal acetate 5mg medicinal products

Referral: Picato

Referral: Ibuprofen Kabi 400 mg Infusionslösung and associated names

Referral: Panexcell