Quality Review of Documents Product Information Template List

Identifier	Term Name	Status
200000029791	SUMMARY OF PRODUCT CHARACTERISTICS	CURRENT
200000029792	1. NAME OF THE MEDICINAL PRODUCT	CURRENT
200000029793	2. QUALITATIVE AND QUANTITATIVE COMPOSITION	CURRENT
200000029794	2.1 General description	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029795	2.2 Qualitative and quantitative composition	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029796	Excipient(s) with known effect	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029797	3. PHARMACEUTICAL FORM	CURRENT
200000029798	4. CLINICAL PARTICULARS	CURRENT
200000029799	4.1 Therapeutic indications	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029800	4.2 Posology and method of administration	CURRENT
200000029801	Posology	CURRENT
200000029802	Paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029803	Method of administration	CURRENT
200000029804	Precautions to be taken before handling or administering the medicinal product	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029805	4.3 Contraindications	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029806	4.4 Special warnings and precautions for use	CURRENT
200000029807	Traceability	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029808	Paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029809	4.5 Interaction with other medicinal products and other forms of interaction	CURRENT
200000029810	Paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029811	4.6 Fertility, pregnancy and lactation	CURRENT
200000029812	Pregnancy	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029813	Breast-feeding	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029814	Fertility	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029815	4.7 Effects on ability to drive and use machines	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029816	4.8 Undesirable effects	CURRENT
200000029817	Paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029818	Reporting of suspected adverse reactions	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029819	4.9 Overdose	CURRENT
200000029820	Paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029821	5. PHARMACOLOGICAL PROPERTIES	CURRENT
200000029822	5.1 Pharmacodynamic properties	CURRENT
200000029823	Mechanism of action	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029824	Pharmacodynamic effects	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029825	Clinical efficacy and safety	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029826	Paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029827	5.2 Pharmacokinetic properties	CURRENT
200000029828	Absorption	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029829	Distribution	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029830	Biotransformation	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029831	Elimination	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029832	Linearity/non-linearity	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000029833	Pharmacokinetic/pharmacodynamic relationship(s)	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029834	5.3 Preclinical safety data	CURRENT
200000029835	Environmental risk assessment (ERA)	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029836	6. PHARMACEUTICAL PARTICULARS	CURRENT
200000029837	6.1 List of excipients	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029838	6.2 Incompatibilities	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029839	6.3 Shelf life	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029840	6.4 Special precautions for storage	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029841	6.5 Nature and contents of container [and special equipment for use, administration or implantation]	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029842	6.6 Special precautions for disposal [and other handling]	CURRENT
200000029843	Use in the paediatric population	CURRENT
200000044347	Level=H5 SmPC custom subsection	CURRENT
200000044333	Level=H4 SmPC custom subsection	CURRENT
200000029844	7. MARKETING AUTHORISATION HOLDER	CURRENT
200000029845	8. MARKETING AUTHORISATION NUMBER(S)	CURRENT
200000029846	9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION	CURRENT
200000029847	10. DATE OF REVISION OF THE TEXT	CURRENT
200000029848	11. DOSIMETRY	CURRENT
200000029849	12. INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS	CURRENT
200000029850	ANNEX II	CURRENT
200000029851	A. [MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND] MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE	CURRENT
200000029852	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE	CURRENT
200000029853	Official batch release	CURRENT
200000029854	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION	CURRENT
200000029855	Periodic safety update reports (PSURs)	CURRENT
200000029856	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT	CURRENT
200000029857	Risk management plan (RMP)	CURRENT
200000029858	Additional risk minimisation measures	CURRENT
200000029859	Obligation to conduct post-authorisation measures	CURRENT
200000029860	E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR [THE CONDITIONAL MARKETING AUTHORISATION] [THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES]	CURRENT
200000029861	LABELLING	CURRENT
200000029862	PARTICULARS TO APPEAR ON [THE OUTER PACKAGING] [AND] [THE IMMEDIATE PACKAGING] {NATURE/TYPE}	CURRENT
200000029863	1. NAME OF THE MEDICINAL PRODUCT	CURRENT
200000029864	2. STATEMENT OF ACTIVE SUBSTANCE(S)	CURRENT
200000029865	3. LIST OF EXCIPIENTS	CURRENT
200000029866	4. PHARMACEUTICAL FORM AND CONTENTS	CURRENT
200000029867	5. METHOD AND ROUTE(S) OF ADMINISTRATION	CURRENT
200000029868	6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN	CURRENT
200000029869	7. OTHER SPECIAL WARNING(S), IF NECESSARY	CURRENT
200000029870	8. EXPIRY DATE	CURRENT
200000029871	9. SPECIAL STORAGE CONDITIONS	CURRENT
200000029872	10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE	CURRENT
200000029873	11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER	CURRENT
200000029874	12. MARKETING AUTHORISATION NUMBER(S)	CURRENT
200000029875	13. BATCH NUMBER[, DONATION AND PRODUCT CODES]	CURRENT
200000029876	14. GENERAL CLASSIFICATION FOR SUPPLY	CURRENT
200000029877	15. INSTRUCTIONS ON USE	CURRENT
200000029878	16. INFORMATION IN BRAILLE	CURRENT
200000029879	17. UNIQUE IDENTIFIER - 2D BARCODE	CURRENT
200000029880	18. UNIQUE IDENTIFIER - HUMAN READABLE DATA	CURRENT
200000029881	MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {NATURE/TYPE}	CURRENT
200000029882	1. NAME OF THE MEDICINAL PRODUCT	CURRENT
200000029883	2. NAME OF THE MARKETING AUTHORISATION HOLDER	CURRENT
200000029884	3. EXPIRY DATE	CURRENT
200000029885	4. BATCH NUMBER[, DONATION AND PRODUCT CODES]	CURRENT
200000029886	5. OTHER	CURRENT
200000029887	MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}	CURRENT
200000029888	1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION	CURRENT
200000029889	2. METHOD OF ADMINISTRATION	CURRENT
200000029890	3. EXPIRY DATE	CURRENT
200000029891	4. BATCH NUMBER[, DONATION AND PRODUCT CODES]	CURRENT
200000029892	5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT	CURRENT
200000029893	6. OTHER	CURRENT
200000029894	PACKAGE LEAFLET	CURRENT
200000029895	1. What X is and what it is used for	CURRENT
200000044346	Level=H3 PL custom subsection	CURRENT
200000029896	2. What you need to know before you [take] [use] X	CURRENT
200000029897	Do not [take] [use] X	CURRENT
200000029898	Warnings and precautions	CURRENT
200000029899	Children [and adolescents]	CURRENT
200000029900	Other medicines and X	CURRENT
200000029901	X with [food] [and] [,] [drink] [and] [alcohol]	CURRENT
200000029902	Pregnancy [and] [,] breast-feeding [and fertility]	CURRENT
200000029903	Driving and using machines	CURRENT
200000029904	X contains {name the excipient(s)}	CURRENT
200000044346	Level=H3 PL custom subsection	CURRENT
200000029905	3. How to [take] [use] X	CURRENT
200000029906	Use in children [and adolescents]	CURRENT
200000029907	If you [take] [use] more X than you should	CURRENT
200000029908	If you forget to [take] [use] X	CURRENT
200000029909	If you stop [taking] [using] X	CURRENT
200000044346	Level=H3 PL custom subsection	CURRENT
200000029910	4. Possible side effects	CURRENT
200000029911	Additional side effects in children [and adolescents]	CURRENT
200000029912	Reporting of side effects	CURRENT
200000044346	Level=H3 PL custom subsection	CURRENT
200000029913	5. How to store X	CURRENT
200000044346	Level=H3 PL custom subsection	CURRENT
200000029914	6. Contents of the pack and other information	CURRENT
200000029915	What X contains	CURRENT
200000029916	What X looks like and contents of the pack	CURRENT
200000029917	Marketing Authorisation Holder and Manufacturer	CURRENT
200000029918	This medicine is authorised in the Member States of the European Economic Area under the following names:	CURRENT
200000029919	This leaflet was last revised in [{MM/YYYY}][{month YYYY}].	CURRENT
200000029920	Other sources of information	CURRENT
200000029921	The following information is intended for healthcare professionals only:	CURRENT
200000044346	Level=H3 PL custom subsection	CURRENT