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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) (1981) Apply European public assessment reports (EPAR) filter Summaries of opinion (87) Apply Summaries of opinion filter Withdrawn applications (304) Apply Withdrawn applications filter Orphan designations (2757) Apply Orphan designations filter Maximum residue limits (801) Apply Maximum residue limits filter Opinions on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 (2392) Apply Periodic safety update report single assessments filter Shortages (38) Apply Shortages filter Opinions on medicines for use outside EU (15) 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) (620) 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 (810) 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 (943) Apply W: decision granting a waiver in all age groups for all conditions or indications filter

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European Commission final decision (537) Apply European Commission final decision filter CMDh final position (18) Apply CMDh final position filter Opinion provided by Committee for Medicinal Products for Human Use (4) Apply Opinion provided by Committee for Medicinal Products for Human Use filter

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Article 29(4) referrals (121) Apply Article 29(4) referrals filter Article 31 referrals (121) Apply Article 31 referrals filter Article 30 referrals (95) Apply Article 30 referrals filter Article 35 (45) Apply Article 35 filter Article 33 (43) Apply Article 33 filter Article 20 procedures (26) Apply Article 20 procedures filter Article 6(12) referrals (prior to January 2010) (21) Apply Article 6(12) referrals (prior to January 2010) filter Article 34 (20) Apply Article 34 filter Article 107 procedures (prior to July 2012) (15) Apply Article 107 procedures (prior to July 2012) filter Article 29 paediatrics (9) Apply Article 29 paediatrics filter Article 36 referrals (prior to July 2012) (9) Apply Article 36 referrals (prior to July 2012) filter Article 107i procedures (9) Apply Article 107i procedures filter Article 13 (6) Apply Article 13 filter Article 13 referrals (6) Apply Article 13 referrals filter Article 6(13) referrals (prior to January 2010) (5) Apply Article 6(13) referrals (prior to January 2010) filter Article 78 (5) Apply Article 78 filter Articles 39 and 40 (4) Apply Articles 39 and 40 filter Article 5(11) referrals (prior to January 2010) (2) Apply Article 5(11) referrals (prior to January 2010) filter Article 82 (2) Apply Article 82 filter

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Centrally and nationally authorised products (mixed) (14) Apply Centrally and nationally authorised products (mixed) filter Centrally authorised product(s) (25) Apply Centrally authorised product(s) filter Nationally authorised product(s) (72) Apply Nationally authorised product(s) filter

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Accelerated assessment (41) Apply Accelerated assessment filter Additional monitoring (212) Apply Additional monitoring filter Biosimilar (2) Apply Biosimilar filter Conditional approval (35) Apply Conditional approval filter Exceptional circumstances (14) Apply Exceptional circumstances filter Generic (6) Apply Generic filter Orphan medicine (88) Apply Orphan medicine filter

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3086 results

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Referral: Janus kinase inhibitors (JAKi) (updated)

tofacitinib, abrocitinib, baricitinib, upadacitinib, filgotinib, associated names: Xeljanz, Cibinqo, Olumiant, Rinvoq, Jyseleca, Article 20 procedures
Status: Opinion provided by Committee for Medicinal Products for Human Use, opinion/position date: 12/01/2023, Last updated: 27/01/2023
List item

Referral: Amfepramone-containing medicinal products (updated)

amfepramone, associated names: Regenon, Tenuate Retard, Amfepramon-Hormosan, Regenon Retard, Article 31 referrals
Status: European Commission final decision, opinion/position date: 10/11/2022, EC decision date: 13/01/2023, Last updated: 20/01/2023
List item

Direct healthcare professional communication (DHPC): INSUMAN RAPID / INSUMAN BASAL / INSUMAN COMB 25 (insulin human): temporary supply shortage (updated)

Active substance: insulin human, DHPC type: Medicine shortage, Last updated: 16/01/2023
List item

Referral: Synchron

Article 31 referrals
Status: European Commission final decision, opinion/position date: 19/05/2022, EC decision date: 28/11/2022, Last updated: 16/12/2022
List item

Referral: Pholcodine-containing medicinal products

pholcodine, Article 107i procedures
Status: CMDh position, opinion/position date: 14/12/2022, Last updated: 16/12/2022
List item

Referral: Nomegestrol and chlormadinone

nomegestrol, chlormadinone, associated names: Zoely, Article 31 referrals
Status: European Commission final decision, opinion/position date: 01/09/2022, EC decision date: 28/11/2022, Last updated: 14/12/2022
List item

Referral: Topiramate

topiramate, Article 31 referrals
Status: Under evaluation, Last updated: 02/12/2022
List item

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

terlipressin, Article 31 referrals
Status: CMDh final position, opinion/position date: 10/11/2022, Last updated: 22/11/2022
List item

Referral: Rubraca

rucaparib, associated names: Rubraca, Article 20 procedures
Status: European Commission final decision, opinion/position date: 21/07/2022, EC decision date: 21/09/2022, Last updated: 17/10/2022
List item

Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage

Active substance: parathyroid hormone, DHPC type: Medicine shortage, Last updated: 04/10/2022
List item

Direct healthcare professional communication (DHPC): Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023

Active substance: belatacept, DHPC type: Medicine shortage, Last updated: 28/09/2022
List item

Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient

Article 82
Status: Under evaluation, opinion/position date: 11/05/2022, Last updated: 14/09/2022
List item

Referral: Procaine benzylpenicillin

Article 82
Status: Under evaluation, opinion/position date: 18/02/2022, Last updated: 08/09/2022
List item

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

Active substance: cetrorelix (as acetate), DHPC type: Medicine shortage, Last updated: 09/08/2022
List item

Referral: Daruph and Anafezyn

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

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

Active substance: hydroxyethyl starch, DHPC type: Post-authorisation measure, Last updated: 26/07/2022
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: 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: Lidocain/Prilocain Idetec and associated names

lidocaine, prilocaine, associated names: Lidocaïne / Prilocaïne 5% Focus, Crème, Article 29(4) referrals
Status: European Commission final decision, opinion/position date: 14/10/2021, Last updated: 21/04/2022
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: 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

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3086 results

Referral: Janus kinase inhibitors (JAKi) (updated)

Referral: Amfepramone-containing medicinal products (updated)

Direct healthcare professional communication (DHPC): INSUMAN RAPID / INSUMAN BASAL / INSUMAN COMB 25 (insulin human): temporary supply shortage (updated)

Referral: Synchron

Referral: Pholcodine-containing medicinal products

Referral: Nomegestrol and chlormadinone

Referral: Topiramate

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

Referral: Rubraca

Direct healthcare professional communication (DHPC): Natpar (parathyroid hormone): Discontinuation of manufacturing at the end of 2024 and update on 100mcg shortage

Direct healthcare professional communication (DHPC): Direct healthcare professional communication (DHPC): NULOJIX (belatacept): Further extension of the temporary restriction in supply up until 3Q 2023

Referral: Veterinary medicinal products containing N-methyl pyrrolidone as an excipient

Referral: Procaine benzylpenicillin

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

Referral: Daruph and Anafezyn

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

Referral: Zynteglo

Referral: Nasolam and associated names

Referral: Lidocain/Prilocain Idetec and associated names

Referral: Etifoxine-containing medicinal products

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