Information note from the meeting of the CMH Committee on Medicinal Products for Human Use on September 5, 2023

Category: Medicines for human use
Reference: MUH (CMH), 07/2023

• The (CMH) of the AEMPS met via telephone conference on September 5, 2023. At this meeting positive information was given about the new drugs mentioned below. This relationship is neither final nor binding.

• The next CMH meeting will take place on October 3, 2023

Generics with official Spanish name (DOE)

• AMPICILLIN/SULBACTAM NETPHARMALAB 1 g/0.5 g powder for solution for injection and EFG perfusion

• ATORVASTATIN PENSA PHARMA 10 mg film-coated tablets EFG

• ATORVASTATIN PENSA PHARMA 20 mg film-coated tablets EFG

• ATORVASTATIN PENSA PHARMA 40 mg film-coated tablets EFG

• ATORVASTATIN PENSA PHARMA 80 mg film-coated tablets EFG

• CITALOPRAM ARISTOGEN 10 mg film-coated tablets EFG

• CITALOPRAM ARISTOGEN 20 mg film-coated tablets EFG

• CITALOPRAM ARISTOGEN 30 mg film-coated tablets EFG

• CITALOPRAM ARISTOGEN 40 mg film-coated tablets EFG

• DAPTOMYCIN TARBIS 350 mg powder for solution for injection and EFG perfusion

• DAPTOMYCIN TARBIS 500 mg powder for solution for injection and EFG perfusion

• DESMOPRESSIN ARISTO 60 micrograms sublingual tablets EFG

• DESMOPRESSIN ARISTO 120 micrograms sublingual tablets EFG

• DESMOPRESSIN ARISTO 240 micrograms sublingual tablets EFG

• DESMOPRESSIN SANDOZ 120 micrograms sublingual tablets EFG

• ESCITALOPRAM GRINDEKS 5 mg film-coated tablets EFG

• ESCITALOPRAM GRINDEKS 10 mg film-coated tablets EFG

• ESCITALOPRAM GRINDEKS 20 mg film-coated tablets EFG

• LOSARTAN/HYDROCHLOROTHIAZIDE CINFA 100 mg/12.5 mg film-coated tablets EFG

• METAMIZOL ABABOR 575 mg hard capsules EFG

• METAMIZOL AIKO PHARMACEUTICALS 575 mg hard capsules EFG

• METAMIZOLE BASE 500 mg/ml EFG solution for injection

• MIRTAZAPINE TEVA-RATIO 15 mg film-coated tablets EFG

• MIRTAZAPINE TEVA-RATIO 30 mg film-coated tablets EFG

• MIRTAZAPINE TEVA-RATIO 45 mg film-coated tablets EFG

• MOXIFLOXACIN NETPHARMALAB 400 mg/250 ml solution for EFG infusion

• OLMESARTAN/AMLODIPINO TECNIGEN 20 mg/5 mg film-coated tablets EFG

• OLMESARTAN/AMLODIPINO TECNIGEN 40 mg/5 mg film-coated tablets EFG

• OLMESARTAN/AMLODIPINO TECNIGEN 40 mg/10 mg film-coated tablets EFG

• OMEPRAZOLE HIKMA 40 mg powder for solution for infusion EFG

• OMEPRAZOLE NORIDEM 40 mg powder for solution for infusion EFG

• PERAMPANEL ELPEN 2 mg film-coated tablets EFG

• PERAMPANEL ELPEN 4 mg film-coated tablets EFG

• PERAMPANEL ELPEN 6 mg film-coated tablets EFG

• PERAMPANEL ELPEN 8 mg film-coated tablets EFG

• PERAMPANEL ELPEN 10 mg film-coated tablets EFG

• PERAMPANEL ELPEN 12 mg film-coated tablets EFG

• PLERIXAFOR SEACROSS 20 mg/ml solution for injection EFG

• PIPERACYLIN/TAZOBACTAM QILU 2 g/0.25 g powder for solution for EFG perfusion

• PIPERACYLIN/TAZOBACTAM QILU 4g/0.5g powder for solution for EFG perfusion

• RIVAROXABAN SANDOZ PHARMACEUTICAL 15 mg + 20 mg film-coated tablets EFG

• RIVAROXABAN STADA 2.5 mg film-coated tablets EFG

• RIVAROXABAN STADA 10 mg film-coated tablets EFG

• RIVAROXABAN STADA 15 mg + 20 mg film-coated tablets EFG

• RIVAROXABAN STADA 15 mg film-coated tablets EFG

• RIVAROXABAN STADA 20 mg film-coated tablets EFG

• SITAGLIPTINA GLN 25 mg film-coated tablets EFG

• SITAGLIPTINA GLN 50 mg film-coated tablets EFG

• SITAGLIPTINA GLN 100 mg film-coated tablets EFG

• SUGAMMADEX BAXTER 100 mg/ml EFG solution for injection

• SUGAMMADEX JUTA 100 mg/ml EFG solution for injection

• SUGAMMADEX KALCEKS 100 mg/ml EFG solution for injection

• SUGAMMADEX VIVANTA 100 mg/ml EFG solution for injection

• SOLIFENACINE/TAMSULOSINE AGE 6 mg/0.4 mg EFG modified-release tablets

• TERIFLUNOMIDE TEVA 14 mg film-coated tablets EFG

• VENLAFAXINE RETARD NORMOGEN 37.5 mg extended-release hard capsules EFG

• VENLAFAXINE RETARD NORMOGEN 75 mg extended-release hard capsules EFG

• VENLAFAXINE RETARD NORMOGEN 150 mg extended-release hard capsules EFG

Branded generics

• AXABA 6 mg/0.4 mg modified-release tablets EFG (solifenacin succinate, tamsulosin hydrochloride) LABORATORIOS ALTER, SA

• JIVOLAR 50 mg/850 mg film-coated tablets EFG

• JIVOLAR 50 mg/1,000 mg film-coated tablets EFG (metformin hydrochloride, sitagliptin phosphate monohydrate) MEDOCHEMIE LIMITED laboratory

• PIXXOSCAN 1.0 mmol/ml EFG solution for injection

• PIXXOSCAN 1.0 mmol/ml solution for injection in a syringe preloaded with EFG (gadobutrol) GE Laboratory HEALTHCARE BIO-SCIENCES, SAU

• SUPOFEN 10 mg/ml solution for infusion EFG (paracetamol) BASI LABORATORIES – INDÚSTRIA FARMACÊUTICA SA

• VIMTRILE 5 mg film-coated tablets EFG

• VIMTRILE 20 mg film-coated tablets EFG (Tadalafil) MEDOCHEMIE LIMITED laboratory

Other medications

• ARIPIPRAZOLE CINFA 20 mg tablets

• ARIPIPRAZOLE NORMON 20 mg tablets

• ARIPIPRAZOLE NORMOGEN 20 mg tablets

• ATORVASTATIN LICONSA 30 mg film-coated tablets

• ATORVASTATIN LICONSA 60 mg film-coated tablets

• ATORVASTATIN PENSA PHARMA 30 mg film-coated tablets

• ATORVASTATIN PENSA PHARMA 60 mg film-coated tablets

• CIFOBAN 136 mmol/l infusion solution (sodium citrate) laboratory FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH

• ELYMBUS 0.1 mg/g eye gel in single-dose container (bimatoprost) LABORATOIRES THEA

• IGANTIBE 200 IU/ml solution for injection in pre-filled syringe (human anti-hepatitis B immunoglobulin) Laboratory INSTITUTO GRIFOLS, SA

• NALOXONE ACCORD 0.4 mg/ml solution for injection and infusion in a pre-filled syringe

• OCTAPLASMALG (0) 45-70 mg/ml powder and solvent for solution for infusion

• OCTAPLASMALG (a) 45-70 mg/ml powder and solvent for solution for infusion

• OCTAPLASMALG (from) 45-70 mg/ml powder and solvent for solution for infusion

• OCTAPLASMALG (b) 45-70 mg/ml powder and solvent for solution for infusion (human plasma protein) OCTAPHARMA SA Laboratory

• OHECON 0.25%/10% medical compressed gas (carbon monoxide, helium) KNIFE IBERICA DE GASES, SAU Laboratory

• PENTASA 4 g rectal suspension (mesalazine) Laboratorio FERRING SAU

• PULMOPRODIFF 0.25%/18% medical compressed gas (carbon monoxide, helium) laboratory KNIFE IBERICA DE GASES, SAU

• VERORAB powder and solvent for suspension for injection in a pre-filled syringe. Rabies vaccine, inactivated (rabies virus, inactivated, Wistar strain (PM/WI 38-1503-3M)) SANOFI PASTEUR laboratory

• TILAK 20 mg/ml skin solution

• TILAK 50 mg/ml skin solution (minoxidil) MEDINFAR laboratory – PRODUCTOS PHARMACEUTICS, SA

• VISIOTAN 50 micrograms/ml eye drop solution in a single-dose container (latanoprost) OmniVision GMBH laboratory

• VITAMIN D3 FARMASIERRA 10,000 IU tablets