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PSUSA outcome published: PSUSA/00010280/202602

PSUSA outcome published: PSUSA/00010947/202602

Pneumococcal Vaccine Factsheet – Information for Patients, Parents and Carers

Patient factsheet providing information on pneumococcal disease and pneumococcal vaccination.

Find product information about medicines

How to get information including patient information leaflets (PILs), details on how the medicine can be used (SPCs) and scientific reports (PARs).

Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products

Class II drug recall: Ranolazine Extended-Release Tablets (Ajanta Pharma Usa Inc)

Failed Dissolution Specifications: below specification Recall D-0010-2027; status Ongoing; distribution: Nationwide in the US..

Class II drug recall: Buprenorphine Hydrochloride (Par Health Usa, Llc)

Crystallization Recall D-0876-2026; status Ongoing; distribution: U.S. Nationwide.

Class II drug recall: Benzoyl Peroxide Wash (Sv Labs Toronto Corporation)

Microbial contamination of topical product. Recall D-0878-2026; status Ongoing; distribution: IL only.

Class II drug recall: Paroxetine Extended-Release Tablets (Apotex Corp.)

Failed dissolution specifications. Recall D-0877-2026; status Ongoing; distribution: US Nationwide..

Class II drug recall: Zoladex (goserelin) implant (Tersera Therapeutics Llc)

Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient outdoor conditions for 25.5 hours. Recall D-0875-2026; status Ongoing; distribution: USA Nationwide.

Class II drug recall: FOCUS PI Hypromellose 0.7% Formula (Aurolab Trust)

Lack of Assurance of Sterility Recall D-0874-2026; status Ongoing; distribution: VA.

Class II drug recall: Estradiol Gel (Amneal Pharmaceuticals, Llc)

Defective Container; packets were found to be either empty or partially full. Recall D-0873-2026; status Ongoing; distribution: Nationwide in the USA..

PSUSA outcome published: PSUSA/00009057/202601

PSUSA outcome published: PSUSA/00001204/202602

PSUSA outcome published: PSUSA/00009266/202601

Medicines: terminated and cancelled manufacturing and wholesale dealer licences

UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.

Register of brokers authorised to deal in human medicines

Current listing of UK brokers authorised to broker human medicines, including company name, registration and address.

Periodic safety update reports (PSURs)

PSUSA outcome published: PSUSA/00002951/202601

PSUSA outcome published: PSUSA/00001583/202602

PSUSA outcome published: PSUSA/00001781/202601

PSUSA outcome published: PSUSA/00001248/202602

PSUSA outcome published: PSUSA/00001955/202602

PSUSA outcome published: PSUSA/00001584/202602

Concept paper on the guideline revision on good pharmacogenomic practice

PRAC rules of procedure

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes

European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure