• Include these codes as defined in http://ema.europa.eu/fhir/CodeSystem/200000029659 version 📦1.0.0

  Code	Display
  000000000000	Code for custom sub-sections (reserved)
  200000029791	SUMMARY OF PRODUCT CHARACTERISTICS
  200000029792	1. NAME OF THE MEDICINAL PRODUCT
  200000029793	2. QUALITATIVE AND QUANTITATIVE COMPOSITION
  200000029794	2.1 General description
  200000029795	2.2 Qualitative and quantitative composition
  200000029796	Excipient(s) with known effect
  200000029797	3. PHARMACEUTICAL FORM
  200000029798	4. CLINICAL PARTICULARS
  200000029799	4.1 Therapeutic indications
  200000029800	4.2 Posology and method of administration
  200000029801	Posology
  200000029802	Paediatric population
  200000029803	Method of administration
  200000029804	Precautions to be taken before handling or administering the medicinal product
  200000029805	4.3 Contraindications
  200000029806	4.4 Special warnings and precautions for use
  200000029807	Traceability
  200000029808	Paediatric population
  200000029809	4.5 Interaction with other medicinal products and other forms of interaction
  200000029810	Paediatric population
  200000029811	4.6 Fertility, pregnancy and lactation
  200000029812	Pregnancy
  200000029813	Breast-feeding
  200000029814	Fertility
  200000029815	4.7 Effects on ability to drive and use machines
  200000029816	4.8 Undesirable effects
  200000029817	Paediatric population
  200000029818	Reporting of suspected adverse reactions
  200000029819	4.9 Overdose
  200000029820	Paediatric population
  200000029821	5. PHARMACOLOGICAL PROPERTIES
  200000029822	5.1 Pharmacodynamic properties
  200000029823	Mechanism of action
  200000029824	Pharmacodynamic effects
  200000029825	Clinical efficacy and safety
  200000029826	Paediatric population
  200000029827	5.2 Pharmacokinetic properties
  200000029828	Absorption
  200000029829	Distribution
  200000029830	Biotransformation
  200000029831	Elimination
  200000029832	Linearity/non-linearity
  200000029833	Pharmacokinetic/pharmacodynamic relationship(s)
  200000029834	5.3 Preclinical safety data
  200000029835	Environmental risk assessment (ERA)
  200000029836	6. PHARMACEUTICAL PARTICULARS
  200000029837	6.1 List of excipients
  200000029838	6.2 Incompatibilities
  200000029839	6.3 Shelf life
  200000029840	6.4 Special precautions for storage
  200000029841	6.5 Nature and contents of container [and special equipment for use, administration or implantation]
  200000029842	6.6 Special precautions for disposal [and other handling]
  200000029843	Use in the paediatric population
  200000029844	7. MARKETING AUTHORISATION HOLDER
  200000029845	8. MARKETING AUTHORISATION NUMBER(S)
  200000029846	9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
  200000029847	10. DATE OF REVISION OF THE TEXT
  200000029848	11. DOSIMETRY
  200000029849	12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
  200000029850	ANNEX II
  200000029851	A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
  200000029852	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
  200000029853	Official batch release
  200000029854	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
  200000029855	Periodic safety update reports (PSURs)
  200000029856	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
  200000029857	Risk management plan (RMP)
  200000029858	Additional risk minimisation measures
  200000029859	Obligation to conduct post-authorisation measures
  200000029860	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
  200000029861	LABELLING
  200000029862	PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}
  200000029863	1. NAME OF THE MEDICINAL PRODUCT
  200000029864	2. STATEMENT OF ACTIVE SUBSTANCE(S)
  200000029865	3. LIST OF EXCIPIENTS
  200000029866	4. PHARMACEUTICAL FORM AND CONTENTS
  200000029867	5. METHOD AND ROUTE(S) OF ADMINISTRATION
  200000029868	6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
  200000029869	7. OTHER SPECIAL WARNING(S), IF NECESSARY
  200000029870	8. EXPIRY DATE
  200000029871	9. SPECIAL STORAGE CONDITIONS
  200000029872	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
  200000029873	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
  200000029874	12. MARKETING AUTHORISATION NUMBER(S)
  200000029875	13. BATCH NUMBER[, DONATION AND PRODUCT CODES]
  200000029876	14. GENERAL CLASSIFICATION FOR SUPPLY
  200000029877	15. INSTRUCTIONS ON USE
  200000029878	16. INFORMATION IN BRAILLE
  200000029879	17. UNIQUE IDENTIFIER - 2D BARCODE
  200000029880	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
  200000029881	MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}
  200000029882	1. NAME OF THE MEDICINAL PRODUCT
  200000029883	2. NAME OF THE MARKETING AUTHORISATION HOLDER
  200000029884	3. EXPIRY DATE
  200000029885	4. BATCH NUMBER[, DONATION AND PRODUCT CODES]
  200000029886	5. OTHER
  200000029887	MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}
  200000029888	1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
  200000029889	2. METHOD OF ADMINISTRATION
  200000029890	3. EXPIRY DATE
  200000029891	4. BATCH NUMBER[, DONATION AND PRODUCT CODES]
  200000029892	5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
  200000029893	6. OTHER
  200000029894	PACKAGE LEAFLET
  200000029895	1. What X is and what it is used for
  200000029896	2. What you need to know before you [take] [use] X
  200000029897	Do not [take] [use] X
  200000029898	Warnings and precautions
  200000029899	Children [and adolescents]
  200000029900	Other medicines and X
  200000029901	X with [food] [and] [,] [drink] [and] [alcohol]
  200000029902	Pregnancy [and] [,] breast-feeding [and fertility]
  200000029903	Driving and using machines
  200000029904	X contains {name the excipient(s)}
  200000029905	3. How to [take] [use] X
  200000029906	Use in children [and adolescents]
  200000029907	If you [take] [use] more X than you should
  200000029908	If you forget to [take] [use] X
  200000029909	If you stop [taking] [using] X
  200000029910	4. Possible side effects
  200000029911	Additional side effects in children [and adolescents]
  200000029912	Reporting of side effects
  200000029913	5. How to store X
  200000029914	6. Contents of the pack and other information
  200000029915	What X contains
  200000029916	What X looks like and contents of the pack
  200000029917	Marketing Authorisation Holder and Manufacturer
  200000029919	This leaflet was last revised in [{MM/YYYY}][{month YYYY}].
  200000029920	Other sources of information
  200000029921	The following information is intended for healthcare professionals only:
  200000044333	Level=H4 SmPC custom subsection
  200000044346	Level=H3 PL custom subsection
  200000044347	Level=H5 SmPC custom subsection

Expansion performed internally based on codesystem Sections v1.0.0 (CodeSystem)

This value set contains 134 concepts