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Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Nervous system disorders, PIP number: P/0470/2023

Opinion/decision on a Paediatric investigation plan (PI...

Mar 6, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Vimpat, lacosamide, d...

EMEA-000325-PIP01-08-M11

EMEA-000325-PIP01-08-M11

Mar 6, 2025 0

EMEA-000325-PIP01-08-M11

Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Endocrine disorders, PIP number: P/0468/2023

Opinion/decision on a Paediatric investigation plan (PI...

Mar 6, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Saxenda, liraglutide,...

Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin hydrochloride, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0467/2023

Opinion/decision on a Paediatric investigation plan (PI...

Mar 6, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Xydalba, dalbavancin ...

EMEA-002963-PIP01-21-M01

EMEA-002963-PIP01-21-M01

Mar 6, 2025 0

EMEA-002963-PIP01-21-M01

Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (177Lu) oxodotreotide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neoplasms benign, malignant and unspecified (incl cysts and polyps), PIP number: P/0461/2023

Opinion/decision on a Paediatric investigation plan (PI...

Mar 6, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Lutathera, lutetium (...

Human medicines European public assessment report (EPAR): Yorvipath, Palopegteriparatide, Date of authorisation: 17/11/2023, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Yorvipath, Palopegteri...

Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiac disorders, PIP number: P/0457/2023

Opinion/decision on a Paediatric investigation plan (PI...

Mar 6, 2025 0

Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, ...

Human medicines European public assessment report (EPAR): Bemrist Breezhaler, indacaterol,mometasone, Date of authorisation: 30/05/2020, Revision: 8, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Bemrist Breezhaler, in...

Human medicines European public assessment report (EPAR): Atectura Breezhaler, indacaterol,mometasone, Date of authorisation: 30/05/2020, Revision: 12, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Atectura Breezhaler, i...

Human medicines European public assessment report (EPAR): Sitagliptin / Metformin hydrochloride Mylan, sitagliptin hydrochloride monohydrate,metformin hydrochloride, Date of authorisation: 16/02/2022, Revision: 4, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 6, 2025 0

Human medicines European public assessment report (EPAR): Sitagliptin / Metformi...

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed), Date of authorisation: 17/04/2013, Date of refusal: 22/02/2013, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Hexacima, diphtheria, ...

Human medicines European public assessment report (EPAR): Dynastat, parecoxib, Date of authorisation: 22/03/2002, Revision: 39, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Dynastat, parecoxib, D...

Human medicines European public assessment report (EPAR): Cimzia, certolizumab pegol, Date of authorisation: 01/10/2009, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Cimzia, certolizumab p...

Human medicines European public assessment report (EPAR): Benepali, etanercept, Date of authorisation: 13/01/2016, Revision: 26, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Benepali, etanercept, ...

Human medicines European public assessment report (EPAR): Zimbus Breezhaler, indacaterol,glycopyrronium,mometasone furoate, Date of authorisation: 03/07/2020, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Zimbus Breezhaler, ind...

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin, Date of authorisation: 16/12/2019, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Quofenix, delafloxacin...

Human medicines European public assessment report (EPAR): Enerzair Breezhaler, indacaterol,glycopyrronium bromide,mometasone, Date of authorisation: 03/07/2020, Revision: 9, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Enerzair Breezhaler, i...

Human medicines European public assessment report (EPAR): Neoclarityn, desloratadine, Date of authorisation: 15/01/2001, Revision: 48, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Neoclarityn, deslorata...

Human medicines European public assessment report (EPAR): Azomyr, desloratadine, Date of authorisation: 15/01/2001, Revision: 54, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Azomyr, desloratadine,...

Human medicines European public assessment report (EPAR): Aerius, desloratadine, Date of authorisation: 15/01/2001, Revision: 52, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 5, 2025 0

Human medicines European public assessment report (EPAR): Aerius, desloratadine,...

Referral: Azithromycin-containing medicinal products for systemic use, azithromycin Article 31 referrals Under evaluation, 05/03/2025

Referral: Azithromycin-containing medicinal products fo...

Mar 5, 2025 0

Referral: Azithromycin-containing medicinal products for systemic use, azithromy...

Veterinary medicines European public assessment report (EPAR): Syvazul BTV 3, bluetongue virus vaccine (inactivated), Status: Authorised

Veterinary medicines European public assessment report ...

Mar 5, 2025 0

Veterinary medicines European public assessment report (EPAR): Syvazul BTV 3, bl...

Veterinary medicines European public assessment report (EPAR): Bluevac-3, bluetongue virus vaccine (inactivated), Status: Authorised

Veterinary medicines European public assessment report ...

Mar 5, 2025 0

Veterinary medicines European public assessment report (EPAR): Bluevac-3, blueto...

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