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What happened to medicines

Withdrawals, quality defects, new contraindications and supply shortages published by the European Medicines Agency and the Romanian medicines agency. We collect them daily and link them to catalogue medicines by active substance.

62 active notices

1460 medicines concerned

2 official sources

Action taken on the medicine

3

Authorisation revoked
Tavneos (avacopan) – recomandare privind revocarea autorizației de punere pe piață în Uniunea Europeană din cauza raportului beneficiu–risc nefavorabil
ANMDMR · 2026-07-16 →

catalogue medicines:

TAVNEOS 10 mg
Authorisation revoked
Tavneos
EMA · 2026-07-16 →

catalogue medicines:

TAVNEOS 10 mg
Authorisation suspended
Emblaveo
EMA · 2025-03-14 →

catalogue medicines:

EMBLAVEO 1,5 g/0,5 g

Safety or quality issues

35

Quality defect
Jentadueto
EMA · 2026-08-20 →

catalogue medicines:

JENTADUETO 2,5mg/1000mg JENTADUETO 2,5mg/850mg
Product information updated
Litfulo
EMA · 2026-08-10 →

catalogue medicines:

LITFULO 50 mg
Adverse event
Medicamentele care conțin desogestrel și etonogestrel – informare privind riscul de meningiom și măsurile de reducere la minimum a acestui risc
ANMDMR · 2026-08-06 →

catalogue medicines:

AZALIA 75 micrograme CERAZETTE 0,075 mg SOFTINETTE 0,075 mg
Quality defect
Vyvgart
EMA · 2026-07-23 →

catalogue medicines:

VYVGART VYVGART 1000 mg
Quality defect
Evrysdi
EMA · 2026-06-12 →

catalogue medicines:

EVRYSDI 0,75 mg/ml EVRYSDI 5 mg
Adverse event
Ontozry (cenobamat): noi cerințe pentru monitorizarea funcției hepatice ca urmare a raportărilor de leziuni hepatice severe
ANMDMR · 2026-05-12 →

catalogue medicines:

ONTOZRY 100 mg ONTOZRY 12,5 mg+25 mg ONTOZRY 150 mg ONTOZRY 200 mg ONTOZRY 50 mg
Quality defect
Avtozma
EMA · 2026-04-03 →

catalogue medicines:

AVTOZMA 20 mg/ml AVTOZMA162 mg ROACTEMRA 162mg ROACTEMRA 20mg/ml TUYORY 162 mg TUYORY 20 mg/ml
Adverse event
Scrisoare adresată profesioniștilor din domeniul sănătății în legătură cu Pachetul de informații pentru pacient referitor la riscul apariției de reacții cutanate, inclusiv reacții adverse cutanate severe (RACS) la pacienții tratați cu medicamentul PADCEV (enfortumab vedotin)
ANMDMR · 2026-02-18 →

catalogue medicines:

PADCEV 20 mg PADCEV 30 mg
Quality defect
Arixtra (fondaparinux sodic): Defect important de calitate legat de acul seringii preumplute
ANMDMR · 2026-02-06 →

catalogue medicines:

ARIXTRA 1,5mg/0,3ml ARIXTRA 10mg/0,8ml ARIXTRA 2,5mg/0,5ml ARIXTRA 5mg/0,4ml ARIXTRA 7,5mg/0,6ml
New contraindication
Remsima
EMA · 2025-12-08 →

catalogue medicines:

FLIXABI 100 mg REMICADE 100 mg REMSIMA 100mg REMSIMA 120mg REMSIMA 40 mg/ml ZESSLY 100 mg
Quality defect
Libtayo
EMA · 2025-11-10 →

catalogue medicines:

LIBTAYO 350 mg
Adverse event
Crysvita (burosumab): informare cu privire la riscul de hipercalcemie severă
ANMDMR · 2025-10-09 →

catalogue medicines:

CRYSVITA 10 mg CRYSVITA 20 mg CRYSVITA 30 mg
Quality defect
Rapamune
EMA · 2025-09-19 →

catalogue medicines:

RAPAMUNE 1 mg
Medication error risk
Rybelsus (semaglutidă orală): risc de eroare de medicație cauzată de introducerea unei noi formulări cu biodisponibilitate crescută
ANMDMR · 2025-09-08 →

catalogue medicines:

OZEMPIC 0,25 mg OZEMPIC 0,5 mg OZEMPIC 1 mg OZEMPIC 2 mg RYBELSUS 1,5 mg RYBELSUS 14 mg RYBELSUS 3 mg RYBELSUS 4 mg and 13
Quality defect
Opzelura
EMA · 2025-04-24 →

catalogue medicines:

JAKAVI JAKAVI 5 mg/ml OPZELURA 15 mg/g RUXOLITINIB MSN 10 mg RUXOLITINIB MSN 15 mg RUXOLITINIB MSN 20 mg RUXOLITINIB MSN 5 mg
Adverse event
Veoza (fezolinetant): risc de apariție a leziunilor hepatice induse medicamentos (LHIM) și recomandări noi privind monitorizarea funcției hepatice înainte de tratament și în timpul tratamentului
ANMDMR · 2025-01-13 →

catalogue medicines:

VEOZA 45 mg
Medication error risk
Keppra
EMA · 2024-12-16 →

catalogue medicines:

LEVETIRACETAM ACCORD 100 mg/ml LEVETIRACETAM ARENA 1000 mg LEVETIRACETAM ARENA 500 mg LEVETIRACETAM AUROBINDO 1000 mg LEVETIRACETAM AUROBINDO 500 mg LEVETIRACETAM DESITIN 1000 mg LEVETIRACETAM DESITIN 250 mg LEVETIRACETAM DESITIN 500 mg and 8
Quality defect
Ibandronic acid Accord
EMA · 2024-12-05 →

catalogue medicines:

ACID IBANDRONIC ACCORD 6 mg ACID IBANDRONIC STADA 150 mg IASIBON 50 mg IASIBON 6mg/6ml OSAGRAND 150 mg OSAGRAND 3 mg/3 ml OSSICA 150 mg Osagrand 150mg, 1 comprimat filmat, Zentiva and 1
Quality defect
Vabysmo
EMA · 2024-10-17 →

catalogue medicines:

VABYSMO 120 mg/ml VABYSMO 120 mg/ml solutie injectabila in seringa preumpluta
Quality defect
Giapreza
EMA · 2024-05-23 →

catalogue medicines:

GIAPREZA 2,5 mg/ml
Adverse event
Paxlovid
EMA · 2024-03-21 →

catalogue medicines:

PAXLOVID 150 mg+100 mg
Quality defect
Simponi
EMA · 2023-08-09 →

catalogue medicines:

GOTENFIA 50 mg SIMPONI 50 mg
Quality defect
Simulect
EMA · 2023-04-21 →

catalogue medicines:

SIMULECT 20 mg
Restricted use
Caprelsa
EMA · 2023-02-28 →

catalogue medicines:

CAPRELSA 100mg CAPRELSA 300 mg Caprelsa 100mg, 30 comprimate filmate, Sanofi
Product information updated
Xalkori
EMA · 2023-02-21 →

catalogue medicines:

XALKORI
New contraindication
Remicade / Flixabi / Inflectra / Remsima / Zessly
EMA · 2022-03-07 →

catalogue medicines:

FLIXABI 100 mg REMICADE 100 mg REMSIMA 100mg REMSIMA 120mg REMSIMA 40 mg/ml ZESSLY 100 mg
Product information updated
Xeljanz
EMA · 2021-07-06 →

catalogue medicines:

XELJANZ 1 mg/ml XELJANZ 11 mg XELJANZ 5 mg
Product information updated
Eylea
EMA · 2021-04-15 →

catalogue medicines:

AFQLIR 40 mg/ml AHZANTIVE 40 mg/ml EYDENZELT 40 mg/ml EYLEA 114,3 mg/ml EYLEA 40 mg/ml MYNZEPLI 40 mg/ml OPUVIZ 40 mg/ml PAVBLU 40 mg/ml and 1
Product information updated
Tecentriq
EMA · 2021-03-25 →

catalogue medicines:

TECENTRIQ 1200 mg TECENTRIQ 1875 mg
Quality defect
Kaletra
EMA · 2020-12-23 →

catalogue medicines:

KALETRA 200mg/50mg KALETRA 80mg/ml+20mg/ml LOPINAVIR/RITONAVIR VIATRIS 100 mg/25 mg LOPINAVIR/RITONAVIR VIATRIS 200 mg/50 mg
Product information updated
Ondexxya
EMA · 2020-11-04 →

catalogue medicines:

ONDEXXYA 200 mg
Medication error risk
Cabazitaxel Accord
EMA · 2020-10-28 →

catalogue medicines:

CABAZITAXEL ACCORD 20 mg/ml CABAZITAXEL AQVIDA 20 mg/ml CABAZITAXEL EVER PHARMA 10 mg/ml CABAZITAXEL FRESENIUS KABI 20 mg/ml CABAZITAXEL MSN 60 mg CABAZITAXEL SANDOZ 10 mg/ml CABAZITAXEL STADA 20 mg/ml ELEBER 60 mg and 1
Quality defect
Tepadina
EMA · 2020-06-01 →

catalogue medicines:

TEPADINA 100 mg TEPADINA 15 mg TEPADINA 400 mg THIOTEPA FRESENIUS KABI 100 mg THIOTEPA FRESENIUS KABI 15 mg THIOTEPA MSN 100 mg THIOTEPA MSN 15 mg
Quality defect
Polivy
EMA · 2020-05-04 →

catalogue medicines:

POLIVY 140mg POLIVY 30mg
Quality defect
Ecalta
EMA · 2020-02-14 →

catalogue medicines:

ANIDULAFUNGINA ACCORD 100 mg ANIDULAFUNGINA ROMPHARM 100 mg ANIDULAFUNGINA TEVA 100 mg ECALTA 100mg

Concluded EU reviews

15

Review concluded
Carbamazepin Tillomed
EMA · 2020-04-30 →

catalogue medicines:

CARBAMAZEPIN BIOEEL 200 mg CARBAMAZEPINA ARENA 400 mg CARBAMAZEPINA ARENA 200 mg CARBAMAZEPINA SLAVIA 200 mg CARBAMAZEPINA TERAPIA 200 mg CARBEPSIL 200 mg CARBEPSIL 400 mg Carbepsil 200mg, 50 comprimate, AC Helcor and 7
Review concluded
Yondelis
EMA · 2020-02-28 →

catalogue medicines:

TRABECTEDIN ACCORD 0,25 mg TRABECTEDIN ACCORD 1 mg TRABECTEDIN EVER PHARMA 0,25 mg TRABECTEDIN EVER PHARMA 1 mg TRABECTEDIN TEVA 0,25 mg TRABECTEDIN TEVA 1 mg TRABECTEDINA STADA 0,25 mg TRABECTEDINA STADA 1 mg and 2
Review concluded
Leuprorelin-containing depot medicinal products
EMA · 2019-06-14 →

catalogue medicines:

CAMCEVI 42 mg ELIGARD 22,5 mg ELIGARD 45 mg LEPTOPROL 5 mg
Review concluded
Lemtrada
EMA · 2019-04-12 →

catalogue medicines:

LEMTRADA 12mg
Review concluded
Paracetamol modified-release
EMA · 2016-07-08 →

catalogue medicines:

APAP FORTE PENTRU COPII 40 mg/ml Apap Forte pentru copii, 40 mg/ml suspensie orală, 85 ml, USP BIOFLU BABY 120 mg/5 ml COLDACT 500 mg DEFEBRYL 500 mg FERVEX DURERE SI FEBRA 500 mg FERVEX DURERE SI FEBRA FORTE 1000 mg FERVEX DURERE SI FEBRA INSTANT 250 mg and 53
Review concluded
Linoladiol N and Linoladiol HN
EMA · 2013-12-20 →

catalogue medicines:

ESTRADIOL BESINS 0,75 mg/doza LENZETTO 1,53 mg/doza
Review concluded
Orlistat
EMA · 2012-02-16 →

catalogue medicines:

XENICAL 120mg Xenical 120 mg, 84 capsule, Roche
Review concluded
Somatropin
EMA · 2011-12-15 →

catalogue medicines:

GENOTROPIN 16 UI/ml (5,3 mg/ml) NORDITROPIN FLEXPRO 10 mg/1,5 ml OMNITROPE 1,3mg/ml OMNITROPE 10 mg/1,5 ml OMNITROPE 15mg/1,5ml OMNITROPE 3,3 mg/ml OMNITROPE 5 mg/1,5 ml OMNITROPE 5mg/ml and 4
Review concluded
Ketoprofen topical
EMA · 2010-07-22 →

catalogue medicines:

FASTUM GEL 25 mg/g KETIFEXIN 25 mg KETIFEXIN 50 mg KETOMAG 100 mg KETOMAG 25 mg/g KETONAL 25 mg/g KETONAL DUO 100 mg KETONAL DUO 150 mg and 14
Review concluded
Etoricoxib
EMA · 2008-11-21 →

catalogue medicines:

ARCOXIA 90 mg ARCOXIA 120 mg ARCOXIA 30 mg ARCOXIA 60 mg DOLOXIB 120 mg DOLOXIB 60 mg DOLOXIB 90 mg ETORICOXIB STADA 120 mg and 23
Review concluded
Moxifloxacin
EMA · 2008-07-24 →

catalogue medicines:

AVELOX 400 mg AVELOX 400 mg/250 ml KIMOKS 400 mg Kimoks 400mg, 5 comprimate, Alkaloid MOFLAXA 400 mg MOFLAXA 400 mg/250 ml MOXIFLOXACINA KABI 400 mg/250 ml MOXIFLOXACINA MISOM 5 mg/ml and 3
Review concluded
Piroxicam
EMA · 2008-01-31 →

catalogue medicines:

FLAMEXIN 20 mg PIROXICAM ARENA 20 mg PIROXICAM ATB 30mg/g PIROXICAM FITERMAN 10 mg/g gel PIROXICAM FITERMAN 30 mg/g PIROXICAM HELCOR 20 mg PIROXICAM LAROPHARM 20 mg PIROXICAM SINTOFARM 20 mg and 2
Review concluded
Aprotinin
EMA · 2007-11-22 →

catalogue medicines:

TRASYLOL
Review concluded
Norfloxacin
EMA · 2006-08-29 →

catalogue medicines:

NOLICIN 400 mg NORFLOXACIN HELCOR 400 mg NORFLOXACIN LAROPHARM 400 mg NORFLOXACINA ARENA 400 mg NORFLOXACINA ATB 400 mg Norfloxacin Helcor 400mg, 10 comprimate filmate, Laropharm
Review concluded
Celecoxib
EMA · 2005-12-06 →

catalogue medicines:

ACLEXA 100 mg ACLEXA 200 mg Aclexa 100mg, 30 capsule, KRKA CELEBREX 100 mg CELEBREX 200 mg CELECOXIB TERAPIA 100 mg CELECOXIB TERAPIA 200 mg CELECOXIB TEVA 100 mg and 3

Availability issues

9

Supply shortage
Comunicare catre profesionistii din domeniul sanatatii privind deficitul de AZACTAM 1g si 2g pulbere pentru solutie injectabila sau perfuzabila (aztreonam)
ANMDMR · 2026-08-14 →

catalogue medicines:

AZACTAM 1000 mg AZACTAM 2 g
Supply shortage
Pegasys
EMA · 2024-11-08 →

catalogue medicines:

PEGASYS 180 microrgrame/0,5ml
Quality defect
Leqvio
EMA · 2023-12-21 →

catalogue medicines:

LEQVIO 284 mg
Supply shortage
Menotropin
EMA · 2023-04-12 →

catalogue medicines:

MENOPUR 1200 UI MENOPUR 600 UI MENOPUR 75 UI MERIOFERT 150 UI MERIOFERT 75 UI MERIOFERT PFS 150 UI MERIOFERT PFS 75 UI MERIOFERT PFS 900UI
Supply shortage
Myalepta
EMA · 2023-03-03 →

catalogue medicines:

MYALEPTA 11,3 mg MYALEPTA 3 mg MYALEPTA 5,8 mg
Supply shortage
Pazenir
EMA · 2023-01-24 →

catalogue medicines:

ABRAXANE 5 mg/ml BUGVI 5 mg/ml NAVERUCLIF 5 mg/ml PACLITAXEL ACCORD 6 mg/ml PACLITAXEL ALBUMINA DR. REDDY 5 mg/ml PACLITAXEL KABI 6 mg/ml PAZENIR SINDAXEL 6 mg/ml
Supply shortage
Natpar
EMA · 2022-10-04 →

catalogue medicines:

NATPAR 50 micrograme/doza
Quality defect
Briviact (in Italy: Nubriveo)
EMA · 2021-12-18 →

catalogue medicines:

ABAVALEX 10 mg ABAVALEX 100 mg ABAVALEX 25 mg ABAVALEX 50 mg ABAVALEX 75 mg BRELUNCOL 10 mg BRELUNCOL 100 mg BRELUNCOL 25 mg and 26
Supply shortage
RoActemra
EMA · 2020-09-03 →

catalogue medicines:

AVTOZMA 20 mg/ml AVTOZMA162 mg ROACTEMRA 162mg ROACTEMRA 20mg/ml TUYORY 162 mg TUYORY 20 mg/ml

Do not stop your treatment based on this information. The link between a notice and a medicine is made automatically, by active substance — the original notice may concern a different product with the same substance, from another manufacturer. Check the official source and talk to your doctor or pharmacist. This list does not replace official sources and is not exhaustive.