This search looks for keywords in all of the website’s content. Search tips
Filter by
- Agenda(36)
- Annex to CHMP highlights(0)
- Annual Report(0)
- Application withdrawal assessment report(0)
- Committee meeting report(0)
- COVID-19 vaccine safety update(0)
- Direct healthcare professional communication(22)
- EPAR - All authorised presentations(0)
- EPAR - Amended Product Information(0)
- EPAR - Assessment report - Variation(0)
- EPAR - Assessment report on maintenance of orphan designation - Initial authorisation(0)
- EPAR - Assessment report on maintenance of orphan designation - Post-authorisation(0)
- EPAR - Conditions imposed on member states for safe and effective use(0)
- EPAR - Full risk management plan(0)
- EPAR - Overview(0)
- EPAR - Paediatric investigation plan compliance statement(0)
- EPAR - Procedural steps taken and scientific information after authorisation(0)
- EPAR - Procedural steps taken before authorisation(0)
- EPAR - Product Information(1)
- EPAR - Public assessment report(0)
- EPAR - Risk-management-plan summary(0)
- EPAR - Scientific conclusion(0)
- EPAR - Scientific Discussion(0)
- EPAR - Scientific Discussion - Variation(0)
- EPAR - Steps taken after authorisation when a cutoff date has been used(0)
- Herbal - Call for data(0)
- Herbal - Herbal monograph(0)
- Herbal - HMPC assessment report(0)
- Herbal - HMPC opinion on a European Union herbal monograph(0)
- Herbal - List of references supporting the assessment report(0)
- Herbal - Overview of comments received during consultation(0)
- Herbal - Summary of assessment report for the public(0)
- Herbal – European Union herbal monograph(0)
- Herbal – European Union list entry(0)
- Leaflet(2)
- Maximum Residue Limits - Divergent opinion(0)
- Maximum Residue Limits - Opinion(0)
- Maximum Residue Limits - Report(0)
- Maximum Residue Limits - Summary of opinion(0)
- Medicine QA(0)
- Medicines under additional monitoring(0)
- Minutes(29)
- Newsletter(0)
- Opinion outside EU - All presentations(0)
- Opinion outside EU - Assessment report - Variation(0)
- Opinion outside EU - Medicine questions and answers(0)
- Opinion outside EU - Procedural steps taken and scientific information after opinion(0)
- Opinion outside EU - Procedural steps taken before opinion(0)
- Opinion outside EU - Product information(0)
- Opinion outside EU - Public assessment report(0)
- Opinion outside EU - Risk-management-plan summary(0)
- Opinion outside EU - Scientific discussion(0)
- Opinion outside EU - Summary for the public(0)
- Opinion outside EU - Summary of opinion(0)
- Opinion outside EU - Summary of opinion - Initial authorisation(0)
- Opinion outside EU - Withdrawal assessment report(0)
- Orphan designation(0)
- Orphan review(0)
- Other(15)
- Overview of comments(0)
- Parallel distribution(0)
- Periodic safety update single assessment(0)
- PIP - Notification of discontinuation of a paediatric development which is covered by an agreed PIP decision(0)
- PIP - Paediatric-investigation-plan summary(0)
- PIP decision(1)
- Position statement(0)
- PRAC recommendation on signal(0)
- Presentation(7)
- Press Release(6)
- Procurement(0)
- Public Statement(0)
- Recommendation on medication errors(0)
- Recruitment(0)
- Referrals document(0)
- Regulatory and procedural guideline(1)
- Report(3)
- Scientific guideline(0)
- Standard Operating Procedure - SOP(0)
- Summary of opinion(0)
- Summary of opinion - Initial authorisation(0)
- Supply shortage(57)
- Template or form(0)
- Withdrawal letter(0)
- Work Instruction - WIN(0)
- Work programme(0)
- Advanced therapies(1797)
- Antimicrobial resistance(270)
- Biologicals(147)
- Biosimilars(649)
- Brexit(121)
- Careers(5)
- Clinical trials(599)
- Compassionate use(17)
- Compliance and inspections(600)
- Corporate(115)
- COVID-19(899)
- Data on medicines(987)
- Early access(201)
- Fees(24)
- Generic and hybrid medicines(2185)
- Governance(707)
- Innovation(1164)
- Maximum residue limit(1001)
- Medication error(28)
- Medicines(47008)
- Medicines for use outside the EU(148)
- (-)Medicine shortages(299)
- Mpox(39)
- Paediatrics(12241)
- Parallel distribution(15)
- Pharmacovigilance(9660)
- Procurement(132)
- Product information(6315)
- Quality of medicines(222)
- Rare diseases(8242)
- Referrals(3388)
- Regulatory and procedural guidance(3520)
- Research and development(495)
- Scientific advice(290)
- Scientific guidelines(1753)
- SME(259)
- Vaccines(1501)
- Veterinary limited markets(64)
Search results (299)
Spexotras : EPAR - Product information
English (EN) (675.49 KB - PDF)
български (BG) (800.13 KB - PDF)
español (ES) (698.59 KB - PDF)
čeština (CS) (839.93 KB - PDF)
dansk (DA) (679.76 KB - PDF)
Deutsch (DE) (744.92 KB - PDF)
eesti keel (ET) (671.55 KB - PDF)
ελληνικά (EL) (797.63 KB - PDF)
français (FR) (774.01 KB - PDF)
hrvatski (HR) (769.65 KB - PDF)
íslenska (IS) (667.42 KB - PDF)
italiano (IT) (727.1 KB - PDF)
latviešu valoda (LV) (775.53 KB - PDF)
lietuvių kalba (LT) (808.73 KB - PDF)
magyar (HU) (762.38 KB - PDF)
Malti (MT) (839.22 KB - PDF)
Nederlands (NL) (744.33 KB - PDF)
norsk (NO) (691.19 KB - PDF)
polski (PL) (786.79 KB - PDF)
português (PT) (710.98 KB - PDF)
română (RO) (813.04 KB - PDF)
slovenčina (SK) (816.74 KB - PDF)
slovenščina (SL) (798.7 KB - PDF)
Suomi (FI) (660.72 KB - PDF)
svenska (SV) (676.69 KB - PDF)
Meeting Summary of the Medicine Shortages (SPOC) Working Party - 14 March 2024
English (EN) (185.24 KB - PDF)
Agenda - Medicine Shortages (SPOC) Working Party 14 March 2024
English (EN) (124.58 KB - PDF)
Creon (pancrelipase/pancreas powder) supply shortage
English (EN) (111.53 KB - PDF)
Emend (aprepitant) supply shortage
English (EN) (113.4 KB - PDF)
EMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain.
MSSG recommendations to strengthen supply chains of critical medicinal products
English (EN) (195.77 KB - PDF)
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) meets in preparation for or during a public health emergency or a major event. The European Medicines Agency (EMA) publishes the agendas and minutes of the meetings of the MSSG as well as adopted documents, when available, on the meetings pages.